Label: MAXIMUM STRENGTH ANTACID ANTIGAS- aluminum hydroxide, magnesium hydroxide, dimethicone suspension
- NDC Code(s): 0363-1691-12
- Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 1, 2022
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- Active ingredients (in each 5 mL teaspoonful)
- Purposes
- Uses
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Warnings
Do not take more than 12 teaspoonfuls in 24 hours or use the
maximum dosage for more than 2 weeks.Ask a doctor before use if you have
- kidney disease
- a magnesium-restricted diet
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
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- package Label
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH ANTACID ANTIGAS
aluminum hydroxide, magnesium hydroxide, dimethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1691 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 400 mg in 5 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg in 5 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 40 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1691-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 09/01/2014 Labeler - WALGREEN COMPANY (008965063) Registrant - GCP Laboratories (965480861) Establishment Name Address ID/FEI Business Operations GCP Laboratories 965480861 manufacture(0363-1691) , pack(0363-1691)