Your browser does not support JavaScript! ANTACID ANTIGAS (MYLANTA) SUSPENSION [AARON INDUSTRIES, INC.]
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ANTACID ANTIGAS (mylanta) suspension
[Aaron Industries, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49580-0106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aluminum Hydroxide (Aluminum Hydroxide) Aluminum Hydroxide200 mg  in 5 mL
Magnesium Hydroxide (Magnesium Hydroxide) Magnesium Hydroxide200 mg  in 5 mL
Dimethicone (Dimethicone) Dimethicone20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
POTASSIUM CITRATE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49580-0106-6177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/08/2009
Labeler - Aaron Industries, Inc. (101896231)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.101896231manufacture, analysis

Revised: 11/2009
 
Aaron Industries, Inc.

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