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

REGULAR STRENGTH ANTACID by

Drug Labeling and Warnings

REGULAR STRENGTH ANTACID by is a Otc medication manufactured, distributed, or labeled by AMERISOURCEBERGEN DRUG CORPORATION, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200mg (equivalent to dried gel, USP)
Magnesium hydroxide 200 mg
Simethicone 20mg

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 four times a day 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 under 12 years: ask a doctor

Other information

• each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg
• store at room temperature tightly closed
• do not freeze

Inactive ingredients

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

Questions or comments?

1-800-540-3765

package label

GOOD NEIGHBOR PHARMACY

compare to Maalox® Regular Strength active ingredients*

NDC: 46122-434-40

Regular Strength

antacid

antacid/antigas

Alumina, Magnesia and Simethicone Oral Suspension

Fast relief of

• acid indigestion
• heartburn
• Sour Stomach
• pressure & bloating

cooling mint flavor

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH ANTACID 
aluminum hydroxide, magnesium hydroxide, dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-434
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-434-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	09/01/2017

Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(46122-434)