Label: ANTACID ANTIGAS - mylanta suspension
- NDC Code(s): 49580-0106-6
- Packager: Aaron Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 11, 2009
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- Active Ingredients
Aluminum hydroxide (equivalent to Dried Gel, USP) 200 mgClose
Magnesium hydroxide 200 mg
Simethicone 20 mg
relieves: • heartburn • sour stomachClose
• acid indigestion • upset stomach due to these symptoms
• symptoms of gas
- Ask a doctor before use if you have
• kidney disease • a magnesium restricted dietClose
- Ask a doctor or pharmacist before use if you are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.Close
- Stop use and ask a doctor if
symptoms last for more than 2 weeksClose
- If pregnant or breast-feeding
ask a health professional before use.Close
- Keep this and all drugs out of the reach of children.
In case of accidental overdose, seek professional assistanceClose
or contact a Poison Control Center immediately.
• shake well before useClose
• 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 freezeClose
• store at room temperature tightly closed
• each teaspoon contains:
potassium 2 mg, magnesium 83 mg
- Inactive Ingredients
benzyl alcohol, flavors, glycerin, hydroxyethyl cellulose,Close
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®
Aaron Industries, Inc.
P.O. Box 801 Lynwood , CA 90262
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0106 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) (Aluminum Hydroxide - UNII:5QB0T2IUN0) Aluminum Hydroxide 200 mg in 5 mL Magnesium Hydroxide (UNII: NBZ3QY004S) (Magnesium Hydroxide - UNII:NBZ3QY004S) Magnesium Hydroxide 200 mg in 5 mL Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 20 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0106-6 177 mL in 1 BOTTLE, PLASTIC 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 Business Operations Aaron Industries, Inc. 101896231 manufacture, analysis