MINTOX MAXIMUM STRENGTH
ac6a47e7-972f-4b82-96da-89926d345e9f
HUMAN OTC DRUG LABEL
May 23, 2025
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aluminum hydroxide, magnesium hydroxide, dimethicone
PRODUCT DETAILS
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE,
DIMETHICONE) SUSPENSION
INDICATIONS & USAGE SECTION
Uses
relieves
- heartburn
- sour stomach
- acid indigestion
- the symptoms referred to as gas
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL teaspoonful)
Aluminum hydroxide 400 mg (equivalent to dried gel, USP)
Magnesium hydroxide 400 mg
Simethicone 40mg
OTC - PURPOSE SECTION
Purposes
Antacid
Antigas
WARNINGS SECTION
Warnings
Ask a doctor before use if you have
• kidney disease
• a magnesium-restricted diet
taking a prescription drug.**Ask a doctor or pharmacist before use if you are **
Antacids may interact with certain prescription drugs.
symptoms last more than 2 weeksStop use and ask a doctor if
ask a health professional before use.If pregnant or breast-feeding,
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
• shake well before use
• do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
• adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor
• children under 12 years: ask a doctor
STORAGE AND HANDLING SECTION
Other information
• magnesium 165 mg, sodium 1 mgeach 5 mL teaspoonful contains:
• store at room temperature
• protect from freezing
• keep tightly closed
•TAMPER-EVIDENT: Do not use if breakaway band on bottle cap is missing or broken.
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzyl alcohol, butylparaben, caramel color, carboxymethylcellulose sodium, D and C yellow no.10, flavor, glycerin, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution