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Name:Antacid Supreme
Manufacturer:Cvs
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTACID SUPREME  - aluminum hydroxide and magnesium hydroxide suspension 
CVS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Aluminum hydroxide(equivalent to Dried Gel, USP) 400 mg
Magnesium hydroxide 135 mg

Purpose

Antacid

Uses

relieves: • heartburn • sour stomach • acid indigestion
• upset stomach due to these symptoms • overindulgence in food and drink

Warnings

Ask a doctor before use if you have
• kidney disease • a magnesium restricted diet

• a calcium 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 for 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 immediately.

Directions

• shake well before use
• do not exceed 18 teaspoons in a 24 hour period or use the
maximum dosage for more than 2 weeks
• adults and children 12 years of age and older: take 2 to 4
teaspoons (10-20 mL) between meals and at
bedtime or as directed by a doctor
• children under 12 years of age: ask a doctor

Other information

• do not freeze
• store at room temperature tightly closed
• each teaspoon contains: sodium 3 mg,
calcium 160 mg, magnesium 56 mg

Other information

• do not freeze
• store at room temperature tightly closed
• each teaspoon contains: sodium 3 mg,
calcium 160 mg, magnesium 56 mg

Inactive ingredients

benzyl alcohol,
flavors, hydroxyethyl cellulose, purified water,
saccharin sodium, simethicone, sodium
carbonate, sorbitol, xanthan gum

Principal Display Panel

CVS Pharmacy
compare to the active ingredients in mylanta
Antacid Liquid Supreme
Fast Acting
Soothing relief of heartburn, acid indigestion, sour stomach
cherry
12 fl oz 355mL
image of label


ANTACID SUPREME 
aluminum hydroxide, magnesium hydroxide suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-015
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 400 mg  in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 135 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
SACCHARIN SODIUM ANHYDROUS  
DIMETHICONE  
SODIUM CARBONATE  
SORBITOL  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (Cherry) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-015-12 355 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 01/07/2009

Labeler - CVS (062312574)
Registrant - Aaron Industries, Inc. (113044205)
Establishment
Name Address ID/FEI Operations
Aaron Industries, Inc. 113044205 manufacture, analysis

Revised: 05/2010 CVS



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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