GAVISCON
Drug Facts
Approved
Approval ID
2d74e5bc-1f10-4fb6-9258-cd906e360013
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 27, 2025
Manufacturers
FDA
Haleon US Holdings LLC
DUNS: 079944263
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aluminum hydroxide and magnesium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0095
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide and magnesium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification
INGREDIENTS (11)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
DIMETHICONE, UNSPECIFIEDInactive
Code: 92RU3N3Y1O
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 254 mg in 5 mL
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM CARBONATEActive
Quantity: 237.5 mg in 5 mL
Code: 0E53J927NA
Classification: ACTIB
aluminum hydroxide and magnesium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0094
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide and magnesium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification
INGREDIENTS (10)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 95 mg in 15 mL
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM CARBONATEActive
Quantity: 358 mg in 15 mL
Code: 0E53J927NA
Classification: ACTIB
aluminum hydroxide and magnesium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0574
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide and magnesium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification
INGREDIENTS (11)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
DIMETHICONE, UNSPECIFIEDInactive
Code: 92RU3N3Y1O
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 254 mg in 5 mL
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM CARBONATEActive
Quantity: 237.5 mg in 5 mL
Code: 0E53J927NA
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 5/27/2025
Principal Display Panel
HALEON
Gaviscon
LIQUID ANTACID
EXTRA STRENGTH
- Fast-Acting Heartburn Relief
- Helps Keep Acid Down for Hours
CHERRY
FLAVOR
12 FL OZ (355 mL)
FRONT: 00213320
BACK: 00213322
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 7/30/2014
Uses
relieves
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 5/27/2025
Active ingredients (in each 5 mL / teaspoonful) Extra Strength
Aluminum hydroxide 254 mg
Magnesium carbonate 237.5 mg
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 5/27/2025
Purposes
Antacid
Antacid
WARNINGS SECTION
LOINC: 34071-1Updated: 5/27/2025
Warnings
Ask a doctor or pharmacist before use if you
- have kidney disease
- are on a sodium-restricted diet or a magnesium-restricted diet
- are taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product (Regular Strength)
- do not take more than 8 tablespoonfuls in 24 hours
- do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
- laxative effect may occur
When using this product (Extra Strength)
- do not take more than 16 teaspoonfuls in 24 hours
- do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor
- laxative effect may occur
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 7/30/2014
Directions (Extra Strength)
- shake well
- take 2-4 teaspoonfuls four times a day or as directed by a doctor
- take after meals and at bedtime
- dispense product only by spoon or other measuring device
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 5/27/2025
Other information (Extra Strength)
***each teaspoon (5 mL) contains:**magnesium 75 mg, sodium 11 mg
- store at up to 25°C (77°F). Avoid freezing.
- keep tightly closed
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 5/27/2025
Inactive ingredients (Extra Strength Cherry)
benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 5/27/2025
Questions or comments?
1-800-452-0051
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 5/27/2025
Additional Information
Do not use if printed inner safety seal under cap is broken or missing.
Trademarks are owned by or licensed to the Haleon group of companies.
©2025 Haleon group of companies or its licensor.
Pat. Info www.productpats.com
Distributed by:
Haleon
Warren, NJ 07059
Made in Mexico