Major Mintox Max

Major Mintox Max
SPL v3
SPL
SPL Set ID 536b143d-a1d7-4972-a90b-248e41937070
Route
ORAL
Published
Effective Date 2013-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (400 mg) Hydroxide Ion (40 mg) Dimethicone
Inactive Ingredients
Butylparaben Benzyl Alcohol Carboxymethylcellulose Sodium Hypromelloses Cellulose, Microcrystalline Propylparaben Water Saccharin Sorbitol Solution D&c Yellow No. 10 Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-02-01

Description

Aluminum hydroxide 400 mg (equivalent to dried gel, USP) Magnesium hydroxide 400 mg Simethicone 40mg

Purpose

Antacid Antigas


Medication Information

Purpose

Antacid Antigas

Description

Aluminum hydroxide 400 mg (equivalent to dried gel, USP) Magnesium hydroxide 400 mg Simethicone 40mg

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas
Section 50565-1

Keep out of reach of children.

Purposes

Antacid

Antigas

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.

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

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)

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

Active Ingredients (in Each 5 Ml Teaspoonful)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg


Structured Label Content

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas
Section 50565-1 (50565-1)

Keep out of reach of children.

Purposes

Antacid

Antigas

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.

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

Package Label (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)

Other Information (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 (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

Active Ingredients (in Each 5 Ml Teaspoonful) (Active ingredients (in each 5 mL teaspoonful))

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg


Advanced Ingredient Data


Raw Label Data

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