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Name:Antacid Antigas
Manufacturer:Aaron Industries, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTACID ANTIGAS  - aluminum hydroxide, magnesium hydroxide and dimethicone suspension 
Aaron Industries, Inc.

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) 200 mg
Magnesium hydroxide 200 mg
Simethicone 20 mg

Uses

relieves: • heartburn • sour stomach
• acid indigestion • upset stomach due to these symptoms
• symptoms of gas

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.

Directions

• shake well before use
• do not exceed 24 teaspoons (120 mL) 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:
potassium 2 mg, magnesium 83 mg

Inactive Ingredients

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

Principal Display Panel

* This Product is not manufactured or distributed by Johnson and Johnson Merck, distributor of Mylanta®

Manufactured By

Aaron Industries, Inc.

P.O. Box 801 Lynwood , CA 90262

image of back label




ANTACID ANTIGAS 
mylanta suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0106
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aluminum Hydroxide (Aluminum Hydroxide) Aluminum Hydroxide 200 mg  in 5 mL
Magnesium Hydroxide (Magnesium Hydroxide) Magnesium Hydroxide 200 mg  in 5 mL
Dimethicone (Dimethicone) Dimethicone 20 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
GLYCERIN  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
POTASSIUM CITRATE  
PROPYLENE GLYCOL  
WATER  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49580-0106-6 177 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 04/08/2009

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

Revised: 11/2009 Aaron Industries, Inc.



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


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