ANTACID- aluminum hydroxide, magnesium hydroxide and simethicone suspension

Antacid by

Drug Labeling and Warnings

Antacid by is a Otc medication manufactured, distributed, or labeled by Safeway, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5mL tsp.)

Aluminum hydroxide (equvi. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antacid

Antigas

Uses

• relieves:
• acid indigestion
• heartburn
• sour stomach
• upset stomach and gas associated with these symptoms

Warnings

Do not take more than 8 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

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 two weeks

Keep out of reach of children.

Directions

• shake well before use.
• adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor
• children under 12 years: consult a doctor

Other information

• each teaspoon contains: magnesium 170 mg, sodium 5 mg
• store at controlled room temperature 20oC-25oC (68oF-77oF)
• do not freeze

Inactive ingredients

flavor, glycerin, hydroxyethylcellulose, methylparaben, propylene glycol, purified water, saccharin sodium, simethicone emulsion, sorbitol

PDP

Compare to Maalox maximum strength liquid cherry active ingredients

Maximum strength

Antacid Liquid

Aluminum Hydroxide 400 mg - Antacid

Magnesium Hydroxide 400 mg - Antacid

Simethicone 40 mg - Antigas

INGREDIENTS AND APPEARANCE

ANTACID 
aluminum hydroxide, magnesium hydroxide and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-508
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)	MAGNESIUM HYDROXIDE	400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-508-05	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	12/12/2015

Labeler - Safeway (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	manufacture(21130-508)