Label: MAALOX ANTACID - aluminum hydroxide, magnesium hydroxide and dimethicone liquid
- NDC Code(s): 54868-2093-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0113-0851
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each 5 mL teaspoon)
Aluminum hydroxide (equiv. to dried gel, USP) 200 mg
Magnesium hydroxide 200 mg
Simethicone 20 mgClose
for the relief of
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
- pressure and bloating commonly referred to as gas
Ask a doctor or pharmacist before use if you are
now taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
do not exceed 16 teaspoonsful (80 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor
- shake well before using
- adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
- children under 12: ask a doctor
- Other information
- each teaspoon contains: calcium 25 mg and magnesium 85 mg
- store at 20°-25°C (68°-77°F)
- does not meet USP requirements for preservative effectiveness
- Inactive ingredients
butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitolClose
- Questions or comments?
- Principal Display Panel
Antacid & Anti-Gas
Fast Relief of:
Sour Stomach & Upset Stomach
Maalox Antacid 12 fl oz (355 mL)
- INGREDIENTS AND APPEARANCE
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54868-2093(NDC:0113-0851) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 200 mg in 5 mL MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 200 mg in 5 mL DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg in 5 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL Product Characteristics Color WHITE (opaque) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-2093-0 355 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 12/12/2006 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel