MINTOX: Package Insert and Label Information

MINTOX- aluminum hydroxide, magnesium hydroxide and dimethicone suspension
A-S Medication Solutions

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.

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)

Magnesium hydroxide 200 mg

Simethicone 20mg

Purposes

Antacid

Antigas

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • 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.

Keep out of reach of children.

Directions

  • shake well before use
  • adults and children 12 years of age and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
  • do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
  • children under 12 years: ask a doctor

Other information

  • each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg
  • store at room temperature and avoid freezing
  • keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

HOW SUPPLIED

Product: 50090-1538

NDC: 50090-1538-0 355 mL in a BOTTLE

aluminum hydroxide, magnesium hydroxide, dimethicone

Label ImageLabel Image
MINTOX
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1538(NDC:0904-5721)
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 CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 200 mg in 5 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
PROPYLPARABEN
WATER
SACCHARIN SODIUM (SACCHARIN)
SORBITOL
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1538-0 355 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 02/01/2011
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1538)

Revised: 09/2021 A-S Medication Solutions

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