MAXIMUM STRENGTH ANTACID- aluminum hydroxide, magnesium hydroxide, dimethicone liquid

MAXIMUM STRENGTH ANTACID by

Drug Labeling and Warnings

MAXIMUM STRENGTH ANTACID by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each teaspoonful = 5 mL)

Aluminum hydroxide 400mg (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 use
• adults and children 12 years and older: take 2 to 4 teaspoonfuls

(10-20 mL), as needed, between meals, at bedtime, or as
directed by a doctor. Do not take more than 12 teaspoonfuls
(60 mL) in 24 hours unless directed by a doctor.

• children under 12: ask a doctor

Other information

• each teaspoonful (5 mL) contains: magnesium 165 mg, sodium 1 mg
• store at room temperature
• protect from freezing
• keep tightly closed
• TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.

Inactive ingredients

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

Questions or comments?

1-800-540-3765

package Label

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH ANTACID 
aluminum hydroxide, magnesium hydroxide, dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-619
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-619-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	05/01/2012

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(68016-619) , pack(68016-619)