How to take Gaviscon Double Action Mint

Check that the cap seal is unbroken before first using this product. For oral use. Shake well before use.

Adults and children 12 years and over: Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day.

Children under 12 years: Should only be taken on medical advice.

Ifyou take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

Turn the leaflet for the further information

After taking Gaviscon Double Action Mint:

If symptoms persist after 7 days consult your doctor

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat.

If you experience these or any other side-effects stop taking the product and consult your doctor immediately.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store Gaviscon Double Action Mint

• Do not use this product after the expiry date (EXP: month/year) shown
• Use within 6 months of opening Keep out of the reach and sight of children
• Do not store above 30°C. Do not refrigerate or freeze.

Further information

Each 10 ml oforal suspension contains 500mg sodium alginate, 213mg sodium bicarbonate and 325mg calcium carbonate as the active ingredients.

The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, sodium saccharin, mint flavour, sodium hydroxide and water. This product does not contain sugar or gluten. Gaviscon Double Action Mint is available in bottles of 150ml, 300ml & 600ml.

Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS.

Export distributors: Reckitt & Colman (Overseas) Ltd., Hull, HU8 7DS, UK.

Gaviscon is a trade mark of the RB group of companies

Text Revised: October 2020

\____________­________________________­________________________­___page 5

1.3.2 Mock-up pil and label

Gaviscon Double Action Peppermint oral suspension National eCTD- 0001785

Reckitt Benckiser

0006 PL 00063 0552 Ex­cipient Update RTQ-1

Before taking Gaviscon Double Action Mint ’ ’ – – – – – ,

Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information fora full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25mmol per 10ml).This medicine contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in eithPeraogf ethe2se please consult your doctor.

The maximum recommended daily dose of this medicinal product contains 1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product if you are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed). page 2

T Taking Other Medicines

D Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines.

This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron preparation, antifungals such as ketoconazole, digoxin and beta-blockers (for heart conditions), neuroleptics (for mental illness), thyroxine, chloroquine (for malaria) and bisphosphonates (for osteoporosis).

How to take Gaviscon Double Action Mi

Check that the cap seal is unbroken before first using this product. For oral use. Shake well before use.

Adults and children 12 years and over: Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day.

Children under 12 years: Should only be taken on medical advice.

Ifyou take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

Turn the leaflet for the further information

After taking Gaviscon Double Action Mint:

If symptoms persist after 7 days consult your doctor

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat.

If you experience these or any other sideP-eaffeects4stop taking the product and consult your doctor immediately. Page 4

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to storeGaviscon Double Action Mint

How to take Gaviscon Double Action Mint

For oral use. Shake well before use.

Adults and children 12 years and over:

Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day.

Children under 12 years: Should only be taken on medical advice. If you take too much of this product you may feel bloated. Itis unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

Possible side effects

How to take Gaviscon Double Action Mint

For oral use. Shake well before use.

Adults and children 12 years and over:

Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day.

Children under 12 years: Should only be taken on medical advice. If you take too much of this product you may feel bloated. Itis unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

Possible side effects

How to take Gaviscon Double Action Mint

For oral use. Shake well before use.

Adults and children 12 years and over: Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day, or as directed by your doctor. Children under 12 years: Should only be taken on medical advice. If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

After taking Gaviscon Double Action

Mint: If symptoms persist after 7 days consult your doctor.

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store Gaviscon Double Action Mint

How to take Gaviscon Double Action Mint

For oral use. Shake well before use.

Adults and children 12 years and over: Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day, or as directed by your doctor. Children under 12 years: Should only be taken on medical advice. If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

After taking Gaviscon Double Action

Mint: If symptoms persist after 7 days consult your doctor.

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store Gaviscon Double Action Mint

How to take Gaviscon Double Action Mint

For oral use. Shake well before use.

Adults and children 12 years and over:

Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day. Children under 12 years: Should only be taken on medical advice.

If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist.

If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

• How to store Gaviscon Double Action MintDo not use this product after the expiry date (EXP: month/year) shown Use within 6 months of opening
• Keep out of the sight and reach of children
• Do not store above 30°C.
• Do not refrigerate or freeze

Further information

Each 10 ml of oral suspension contains 500mg sodium alginate, 213mg sodium bicarbonate and 325mg calcium carbonate as the active ingredients. The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, sodium saccharin, mint flavour, sodium hydroxide and water.

This product does not contain sugar or gluten. Gaviscon Double Action Mint is available in bottles of 150ml, 300ml, 500ml & 600ml.

Manufacturer and PL Holder in UK:

Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS.

Gaviscon is a trade mark of the RB group of companies

Text Revised: October 2020

0000000

GAVISCON

How to take Gaviscon Double Action Mint

Check that the cap seal is unbroken before first using this product.

For oral use. Shake well before use.

Adults and children 12 years and over:

Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day. Children under 12 years: Should only be taken on medical advice.

If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist.

If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

• How to store Gaviscon Double Action MintDo not use this product after the expiry date (EXP: month/year) shown Use within 6 months of opening
• Keep out of the sight and reach of children
• Do not store above 30°C.
• Do not refrigerate or freeze

Further information

Each 10 ml of oral suspension contains 500mg sodium alginate, 213mg sodium bicarbonate and 325mg calcium carbonate as the active ingredients. The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, sodium saccharin, mint flavour, sodium hydroxide and water.

This product does not contain sugar or gluten. Gaviscon Double Action Mint is available in bottles of 150ml, 300ml, 500ml & 600ml.

Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS.

Gaviscon is a trade mark of the RB group of companies

Text Revised: October 2020

0000000

PATIENT INFORMATION LEAFLET

GAVISCON DOUBLE ACTION MINT Sodium alginate, Sodium bicarbonate, Calcium carbonate indigestion, which may occur, for example, following meals or during pregnancy and for symptoms of excess stomach acidity (hyperacidity).

Before taking Gaviscon Double Action Mint Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information for a full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25mmol per 10ml). This medicine contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in either of these please consult your doctor.

The maximum recommended daily dose of this medicinal product contains 1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product if you are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed).

Taking Other Medicines

Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines. This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron preparation, antifungals such as ketoconazole, digoxin and 0000000

Possible side effects

How to take Gaviscon Double Action Mint

How to take Gaviscon Double Action Mint

। Check that the cap seal is unbroken before first [ using this product.

। For oral use. Shake well before use.

। Adults and children 12 years and over: [Take 10–20ml (two to four 5ml spoonfuls) after । meals and at bedtime, up to four times a day.

[ Children under 12 years: Should only be 'taken on medical advice.

I If you take too much of this product you may [feel bloated. It is unlikely to cause you any 'harm, but please consult your doctor or [pharmacist.

1 If you forget a dose it is not necessary to double । the dose next time, just carry on taking as [before.

' After taking Gaviscon Double Action Mint:

If symptoms persist after 7 days consult your doctor.

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store Gaviscon Double Action Mint

• Do not use this product after the expiry date (EXP: month/year) shown
• Use within 6 months of opening Keep out of the reach and sight of children
• Do not store above 30°C. Do not refrigerate or freeze.

Further information

Each 10 ml oforal suspension contains 500mg sodium alginate, 213mg sodium bicarbonate and 325mg calcium carbonate as the active ingredients.

The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, sodium saccharin, mint flavour, sodium hydroxide and water. This product does not contain sugar or gluten. Gaviscon Double Action Mint is available in bottles of 150ml, 300ml & 600ml.

Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS.

Export distributors: Reckitt & Colman (Overseas) Ltd., Hull, HU8 7DS, UK.

Gaviscon is a trade mark of the RB group of companies

Text Revised: October 2020

\____________­________________________­________________________­___page 5

1.3.2 Mock-up pil and label

Gaviscon Double Action Peppermint oral suspension National eCTD- 0001785

Reckitt Benckiser

0006 PL 00063 0552 Ex­cipient Update RTQ-1

Before taking Gaviscon Double Action Mint ’ ’ – – – – – ,

Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information fora full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25mmol per 10ml).This medicine contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in eithPeraogf ethe2se please consult your doctor.

The maximum recommended daily dose of this medicinal product contains 1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product if you are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed). page 2

T Taking Other Medicines

D Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines.

This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron preparation, antifungals such as ketoconazole, digoxin and beta-blockers (for heart conditions), neuroleptics (for mental illness), thyroxine, chloroquine (for malaria) and bisphosphonates (for osteoporosis).

How to take Gaviscon Double Action Mi

Check that the cap seal is unbroken before first using this product. For oral use. Shake well before use.

Adults and children 12 years and over: Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day.

Children under 12 years: Should only be taken on medical advice.

Ifyou take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

Turn the leaflet for the further information

After taking Gaviscon Double Action Mint:

If symptoms persist after 7 days consult your doctor

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat.

If you experience these or any other sideP-eaffeects4stop taking the product and consult your doctor immediately. Page 4

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to storeGaviscon Double Action Mint

• Do not use this product after the expiry date (EXP: month/year) shown
• Use within 6 months of opening Keep out of the reach and sight of children
• Do not store above 30°C. Do not refrigerate or freeze.

Further information

Each 10 ml of oral suspension contains 500mg sodium alginate, 213mg sodium bicarbonate and 325mg calcium carbonate as the active ingredients.

The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, sodium saccharin, mint flavour, sodium hydroxide and water. This product does not contain sugPaar goregl5uten. Gaviscon Double Action Mint is available in bottles of 150ml, 300ml & 600ml.

Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS.

Export distributors: Reckitt & Colman (Overseas) Ltd., Hull, HU8 7DS, UK. Gaviscon is a trade mark of the RB group of companies

Text Revised: October 2020

1.3.2 Mock-up pil and label

Gaviscon Double Action Peppermint oral suspension National eCTD- 0001785

30 mm

PATIENT INFORMATION LEAFLET

I GAVISCON DOUBLE ACTION MINT

Sodium alginate

Sodium bicarbonate

Calcium carbonate

Please read this leaflet carefully before you take this medicine. If you are not sure about anything ask your pharmacist or doctor.

What is Gaviscon Double Action Mint and What is it used for?

Gaviscon Double Action Mint is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate and works in two ways:

• 1) Neutralising excess stomach acid to relieve the pain and discomfort.

• 2) Forming a protective barrier over the stomach contents to soothe the burning pain in your chest.

Gaviscon Double Action Mint is used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, which may occur, for example, following meals or during pregnancy and for symptoms of excess stomach acidity (hyperacidity).

Before taking Gaviscon Double Action Mint Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information for a full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25mmol per 10ml). This medicine contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in either of these please consult your doctor.

The maximum recommended daily dose of this medicinal product contains 1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product ifyou are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed).

Taking Other Medicines

Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines. This is especially important if you are taking antihistamines, 0000000

1.3.2 Mock-up pil and label

177.8 mm

6mm । 13.5mm I 6mm

30 mm

PATIENT INFORMATION LEAFLET

I GAVISCON DOUBLE ACTION MINT Sodium alginate

Sodium bicarbonate

Calcium carbonate

Please read this leaflet carefully before you take this medicine. If you are not sure about anything ask your pharmacist or doctor.

What is Gaviscon Double Action Mint and What is it used for?

Gaviscon Double Action Mint is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate and works in two ways:

• 1) Neutralising excess stomach acid to relieve the pain and discomfort.

• 2) Forming a protective barrier over the stomach contents to soothe the burning pain in your chest.

Gaviscon Double Action Mint is used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, which may occur, for example, following meals or during pregnancy and for symptoms of excess stomach acidity (hyperacidity).

Before taking Gaviscon Double Action Mint Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information for a full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25mmol per 10ml). This medicine contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in either of these please consult your doctor.

The maximum recommended daily dose of this medicinal product contains 1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product if you are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed). Taking Other Medicines

Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines. This is especially important if you are taking antihistamines, 0000000

1.3.2 Mock-up pil and label

GaviSMOncD-UUbprACOOedpep­permint oral suspension National eCTD- 0001785

Gaviscon Double Action Peppermint oral suspension National eCTD- 0001785

PATIENT INFORMATION LEAFLET GAVISCON DOUBLE ACTION MINT

Sodium alginate

Sodium bicarbonate

Calcium carbonate

Please read this leaflet carefully before you take this medicine. If you are not sure about anything ask your pharmacist or doctor.

What is Gaviscon Double Action Mint and what is it used for?

Gaviscon Double Action Mint is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate and works in two ways:

• 1) Neutralising excess stomach acid to relieve the pain and discomfort.

• 2) Forming a protective barrier over the stomach contents to soothe the burning pain in your chest.

Gaviscon Double Action Mint is used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, which may occur, for example, following meals or during pregnancy and for symptoms of excess stomach acidity (hyperacidity).

Before taking Gaviscon Double Action Mint

Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information for a full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25 mmol per 10ml). This medicine contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in either of these please consult your doctor. The maximum recommended daily dose of this medicinal product contains 1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product if you are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed).

Taking Other Medicines

Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines. This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as 0000000

norfloxacin), iron preparation, antifungals such as ketoconazole, digoxin and beta-blockers (for heart conditions), neuroleptics (for mental illness), thyroxine, chloroquine (for malaria) and biphosphonates (for osteoporosis).

How to take Gaviscon Double Action Mint

For oral use. Shake well before use.

Adults and children 12 years and over: Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day, or as directed by your doctor. Children under 12 years: Should only be taken on medical advice. If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

After taking Gaviscon Double Action

Mint: If symptoms persist after 7 days consult your doctor.

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store Gaviscon Double Action Mint

• Use within 6 months of opening
• Keep out of the sight and reach of children Do not store above 30°C.

Do not refrigerate or freeze

Further information

Each 10 ml of oral suspension contains 500mg sodium alginate, 213mg sodium bicarbonate and 325mg calcium carbonate as the active ingredients.

The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, sodium saccharin, mint flavour, sodium hydroxide and water. This product does not contain sugar or gluten.

Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS.

Gaviscon is a trade mark of the RB group of companies

Text Revised: October 2020

0000000

1.3.2 Mock-up pil and label

PATIENT INFORMATION LEAFLET GAVISCON DOUBLE ACTION MINT

Sodium alginate

Sodium bicarbonate

Calcium carbonate

Please read this leaflet carefully before you take this medicine. If you are not sure about anything ask your pharmacist or doctor.

What is Gaviscon Double Action Mint and what is it used for?

Gaviscon Double Action Mint is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate and works in two ways:

• 1) Neutralising excess stomach acid to relieve the pain and discomfort.

• 2) Forming a protective barrier over the stomach contents to soothe the burning pain in your chest.

Gaviscon Double Action Mint is used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, which may occur, for example, following meals or during pregnancy and for symptoms of excess stomach acidity (hyperacidity).

Before taking Gaviscon Double Action Mint

Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information for a full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25 mmol per 10ml). This medicine contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in either of these please consult your doctor. The maximum recommended daily dose of this medicinal product contains 1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product if you are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed).

Taking Other Medicines

Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines. This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as 0000000

norfloxacin), iron preparation, antifungals such as ketoconazole, digoxin and beta-blockers (for heart conditions), neuroleptics (for mental illness), thyroxine, chloroquine (for malaria) and biphosphonates (for osteoporosis).

How to take Gaviscon Double Action Mint

For oral use. Shake well before use.

Adults and children 12 years and over: Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day, or as directed by your doctor. Children under 12 years: Should only be taken on medical advice. If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist. If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

After taking Gaviscon Double Action

Mint: If symptoms persist after 7 days consult your doctor.

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store Gaviscon Double Action Mint

• Use within 6 months of opening
• Keep out of the sight and reach of children Do not store above 30°C.

Do not refrigerate or freeze

Further information

Each 10 ml of oral suspension contains 500mg sodium alginate, 213mg sodium bicarbonate and 325mg calcium carbonate as the active ingredients.

The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, sodium saccharin, mint flavour, sodium hydroxide and water. This product does not contain sugar or gluten.

Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS.

Gaviscon is a trade mark of the RB group of companies

Text Revised: October 2020

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1.3.2 Mock-up pil and label

PATIENT INFORMATION LEAFLET

GAVISCON DOUBLE ACTION MINT Sodium alginate, Sodium bicarbonate, Calcium carbonate indigestion, which may occur, for example, following meals or during pregnancy and for symptoms of excess stomach acidity (hyperacidity).

Before taking Gaviscon Double Action Mint Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information for a full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25mmol per 10ml). This medicine contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in either of these please consult your doctor.

The maximum recommended daily dose of this medicinal product contains 1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product if you are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed).

Taking Other Medicines

Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines. This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron preparation, antifungals such as ketoconazole, digoxin and 0000000

'beta-blockers"

(for heart conditions), neuroleptics (for mental illness), thyroxine, chloroquine

(for malaria) and bisphosphonates (for osteoporosis).

How to take Gaviscon Double Action Mint

For oral use. Shake well before use.

Adults and children 12 years and over:

Take 10–20ml (two to four 5ml spoonfuls) after meals and at bedtime, up to four times a day.

Children under 12 years: Should only be taken on medical advice.

If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist.

If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.

After taking Gaviscon Double Action Mint:

• Do not store above 30°C.
• Do not refrigerate or freeze

Further information

Each 10 ml of oral suspension contains 500mg sodium alginate, 213mg sodium bicarbonate and 325mg calcium carbonate as the active ingredients. The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, sodium saccharin, mint flavour, sodium hydroxide and water.

This product does not contain sugar or gluten. Gaviscon Double Action Mint is available in bottles of 150ml, 300ml & 600ml.

Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS.

Gaviscon is a trade mark of the RB group of companies

Text Revised: October 2020

1.3.2 Mock-up pil and label

..Gaviscon Double Action Peppermint oral suspension National eCTD 0001785—

1.3.2 Mock-up Proposed

1 6mm 1 13.5mm 1 6mm 1

56.5mm

।30 mm

PATIENT INFORMATION LEAFLET GAVISCON DOUBLE ACTION MINT

Sodium alginate, Sodium bicarbonate, Calcium carbonate

Please read this leaflet carefully before you take this medicine. If you are not sure about anything ask your pharmacist or doctor.

What is Gaviscon Double Action Mint and what is it used for?

Gaviscon Double Action Mint is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate and works in two ways:

• 1) Neutralising excess stomach acid to relieve the pain and discomfort.

• 2) Forming a protective barrier over the stomach contents to soothe the burning pain in your chest.

Gaviscon Double Action Mint is used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, which may occur, for example, following meals or during pregnancy and for symptoms of excess stomach acidity (hyperacidity).

Before taking Gaviscon Double Action Mint Do not take this product if:

• You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see further information for a full list of ingredients).

Take special care before treatment with Gaviscon Double Action Mint:

This medicine contains calcium (3.25mmol per 10ml). This medicine contains 127.88 mg in each 10 ml. This is equivalent to 6.4 % of the recommended maximum daily dietary intake of sodium for an adult. If you have been advised to follow a diet restricted in either of these please consult your doctor.

The maximum recommended daily dose of this

daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

You can take this product if you are pregnant or breast feeding.

This product contains methyl (E218) and propyl (E216) parahydroxyben­zoates which may cause allergic reactions (possibly delayed).

Taking Other Medicines

Do not take this product within two hours of interfere with the action of some other medicines. This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron preparation, antifungals such as ketoconazole, digoxin and 0000000

ibeta-blockers

| (for heart conditions), neuroleptics (for mental

[ illness), thyroxine, chloroquine । (for malaria) and bisphosphonates (for osteoporosis).

'

How to take Gaviscon Double Action Mint

। Check that the cap seal is unbroken before first [ using this product.

। For oral use. Shake well before use.

। Adults and children 12 years and over: [Take 10–20ml (two to four 5ml spoonfuls) after । meals and at bedtime, up to four times a day.

[ Children under 12 years: Should only be 'taken on medical advice.

I If you take too much of this product you may [feel bloated. It is unlikely to cause you any 'harm, but please consult your doctor or [pharmacist.

1 If you forget a dose it is not necessary to double । the dose next time, just carry on taking as [before.

' After taking Gaviscon Double Action Mint:

If symptoms persist after 7 days consult your doctor.

Possible side effects

Very rarely (less than 1 in 10,000 patients treated) an allergic reaction to the ingredients may occur. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store Gaviscon Double Action Mint

• Use within 6 months of opening
• Keep out of the sight and reach of children
• Do not store above 30°C.
• Do not refrigerate or freeze