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Name:Antacid Antigas Maximum Strength
Manufacturer:Premier Value
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTACID ANTIGAS MAXIMUM STRENGTH  - aluminum hydroxide, magnesium hydroxide and dimethicone suspension 
Premier Value

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 400 mg
Simethicone 40 mg

Purpose

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 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.

Other information


store at room temperature tightly closed • do not freeze

each teaspoon contains:

potassium 2 mg, magnesium 167 mg

Inactive ingredients

benzyl alcohol,
flavors, glycerin, hydroxyethyl cellulose,
potassium citrate, propylene glycol,
purified water, sorbitol

Principal Display Panel

This product is not manufacture or distributed by johnson and johnson Merck, distributor of Mylanta



image of label


ANTACID ANTIGAS MAXIMUM STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-050
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 400 mg  in 5 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE 40 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
POTASSIUM CITRATE  
PROPYLENE GLYCOL  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor LEMON (Lemon) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68016-050-12 355 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 06/03/2009

Labeler - Premier Value (101668460)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
Name Address ID/FEI Operations
Aaron Industries, Inc. 101896231 manufacture, analysis

Revised: 11/2009 Premier Value



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


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