CAREONE ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone suspension

CareOne Antacid by

Drug Labeling and Warnings

CareOne Antacid by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

Aluminum hydroxide (equiv. to dried gel, USP) 800 mg

Magnesium hydroxide 800 mg

Simethicone 80 mg

Purpose

Antacid

Antigas

Uses

for the relief of

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms
• pressure and bloating commonly 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

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not take more than 40 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Keep out of reach of children.

Directions

• shake well before using
• only use the dose cup provided
• adults and children 12 years and older: take 10 mL to 20 mL two times a day or as directed by a physician
• do not take more than 40 mL in 24 hours or use the maximum dosage for more than 2 weeks
• children under 12 years: consult a physician

Other information

• each 10 mL contains: magnesium 350 mg and sodium 3 mg
• does not meet USP requirements for preservative effectiveness
• store at 20-25°C (68-77°F)
• protect from freezing

Inactive ingredients

butylparaben, flavor, glycerin, hydroxyethyl cellulose, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

ADVANCED MAXIMUM STRENGTH LIQUID ANTACID

Aluminum Hydroxide, Magnesium Hydroxide, Simethicone

Antacid/Antigas

Cherry Flavor

ALCOHOL 0.1%

Soothing Relief of Heartburn, Acid Indigestion, Bloating (Gas), Pressure

Gluten Free

12 FL OZ (355 mL)

OUR PHARMACISTS RECOMMEND

INGREDIENTS AND APPEARANCE

CAREONE ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-588
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (opaque)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-588-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/10/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	09/10/2013

Labeler - American Sales Company (809183973)