MINTOX MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

MINTOX MAXIMUM STRENGTH by

Drug Labeling and Warnings

MINTOX MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by MAJOR Pharmaceuticals Inc., GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

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

Magnesium hydroxide 400 mg

Simethicone 40mg

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.

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)

INGREDIENTS AND APPEARANCE

MINTOX MAXIMUM STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5725
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5725-14	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	02/01/2011

Labeler - MAJOR Pharmaceuticals Inc. (191427277)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(0904-5725)