Label: MAXIMUM STRENGTH ANTACID/ ANTIGAS- aluminum hydroxide, magnesium hydroxide, dimethicone suspension
- NDC Code(s): 0536-1318-83
- Packager: RUGBY LABORATORIES
- 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.
Updated October 22, 2020
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- Active ingredients (in each 10 mL dose)
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
- shake well before use
- adults and children 12 years of age and over: 10 mL-20 mL (1 - 2 doses) between meals as needed, at bedtime, or as directed by a doctor
- do not exceed 60 mL (6 doses) in any 24 hour period
- do not use the maximum dosage for more than 2 weeks
- children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- package Label
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH ANTACID/ ANTIGAS
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1318 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 800 mg in 10 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 800 mg in 10 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg in 10 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:0536-1318-83 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 08/01/2020 Labeler - RUGBY LABORATORIES (079246066) Registrant - GCP Laboratories (965480861) Establishment Name Address ID/FEI Business Operations GCP Laboratories 965480861 manufacture(0536-1318)