Active Ingredients (In Each 5 Ml Teaspoonful)
Aluminum hydroxide 400 mg (equivalent to dried gel, USP)
Magnesium hydroxide 400 mg
Simethicone 40mg
Mintox Maximum Strength Suspension
FDA Label NDC 0904-5725
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals Inc. for the product Mintox Maximum Strength (NDC 0904-5725). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml teaspoonful), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antacid
Antigas
Uses
relieves
- heartburn
- sour stomach
- acid indigestion
- the symptoms referred to as gas
Warnings
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- shake well before using
- adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day or as directed by a physician
- do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks.
- children under 12 years: consult a physician
Other Information
- each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
- keep tightly closed
- store at room temperature and avoid freezing
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
Package Label
NDC 0904-5725-14
MAJOR
Mintox
Maximum Strength
antacid/antigas
Alumina, Magnesia and Simethicone Oral Suspension USP
Fast Relief of:
HEARTBURN
ACID INDIGESTION
PRESSURE AND BLOATING
Lemon Creme
*compare to the active ingredients of Maalox Advanced Maximum Strength
12 FL OZ (355 mL)
* Please review the disclaimer below.
