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

ANTACID MAXIMUM STRENGTH by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

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

Purposes

Antacid

Antigas

Uses

relieves

• heartburn
• sour stomach
• acid indigestion
• upset stomach due to these symptoms
• symptoms of 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

presently 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 this and all drugs out of the reach of children.

in case of accidental overdose, seek professional assistance or contact a poison control center (1-800-222-1222) immediately.

Directions

• shake well before use
• do not exceed 12 teaspoons (60 mL) in a 24 hour period or use the maximum dosage for more than 2 weeks
• adults and children 12 years and older: take 2 to 4 teaspoons (10-20 mL) between meals, at bedtime, or as directed by a doctor
• children under 12 years: ask a doctor

Other information

• each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
• do not freeze
• store at room temperature tightly closed

Inactive ingredients

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

package label

Sunmark

compare to MYLANTA Maximum Strength active ingredients

NDC: 49348-303-39

antacid

Maximum Strength

antacid/antigas

Aluminum Hydroxide 400 mg
Magnesium Hydroxide 400 mg
Simethicone 40 mg

Fast acting

fast soothing relief of

heartburn,

acid indigestion,

sour stomach,

pressure & bloating

ORIGINAL

Alcohol: 0,5%

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

ANTACID MAXIMUM STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-303
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)

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: 49348-303-39	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/01/2012

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(49348-303)