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Name:Antacid Mint
Manufacturer:Select Brand
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTACID MINT  - aluminum hydroxide, magnesium hydroxide and dimethicone suspension 
Select Brand

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, saccharin sodium

Principal Display Panel

Select Brand the lower price name brand
Regular Strength Antacid
Alumina, Magnesia, and Simethicone Oral Suspension USP
Antigas Fast Relief of
Acid Indigestion, Heartburn, Sour Stomach, Gas
Mint Creme Flavor
Satisfaction Guaranteed
Compare to the active ingredients of Regular Strength Maalox
12 fl oz 355mL
image of label


ANTACID MINT 
aluminum hydroxide, magnesium hydroxide and dimethicone suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-540
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  
SACCHARIN SODIUM ANHYDROUS  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT (mint flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15127-540-73 355 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 - Select Brand (043562370)
Registrant - Aaron Industries, Inc. (113044205)
Establishment
Name Address ID/FEI Operations
Aaron Industries, Inc. 113044205 manufacture, analysis

Revised: 11/2009 Select Brand



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


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