CALMICID AC  MAXIMUM STRENGTH ACID REDUCER - famotidine tablet, film coated 
Melaleuca, Inc.

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Calmicid AC Content of Label

Active Ingredient (in each tablet)
Famotidine USP 20 mg

Uses

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods or beverages
  

Warnings
Allergy Alert: Do not use if you are allergic to famotidine or other acid reducers

Directions

• adults and children 12 years and over:
• • to relieve symptoms, swallow 1 tablet with a glass of water.  Do not chew.
  • to prevent symptoms, swallow 1 tablet with a glass of water anytime from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
  • do not use more than 2 tablets in 24 hours
• children under 12 years ask a doctor.
  

Inactive ingredients  colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide.

Questions?  call 1-800-282-3000

Purpose
Acid reducer

Ask a doctor before use if you have

• frequent wheezing, particularly with heartburn
• unexpected weight loss
• nausea or vomiting
• stomach pain
• had heartburn over 3 months. This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating, or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  

Stop use and ask a doctor if

• your heartburn continues or worsens
• you need to take this product for more than 14 days
  

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222).

Other information

• store at 20° to 25°C (68° to 77°F)
• protect from moisture
  

• read the directions and warnings before use
• keep the carton. It contains important information.
  

Do not use

• with other acid reducers
• if you have kidney disease, except under the advice and supervision of a doctor
• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor
  

CALMICID AC   MAXIMUM STRENGTH ACID REDUCER famotidine   tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54473-167 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Famotidine (Famotidine) Famotidine 20 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   Hydroxypropyl Cellulose   HYPROMELLOSES   Magnesium Stearate   Cellulose, Microcrystalline   Polyethylene Glycol 400   STARCH, CORN   Talc   Titanium Dioxide

Product Characteristics Color white (white) Score no score Shape ROUND (Round bioconvex) Size 8mm Flavor Imprint Code 036 Contains

Packaging # NDC Package Description Multilevel Packaging 1 54473-167-50 1 BOTTLE In 1 CARTON contains a BOTTLE 1 50 TABLET In 1 BOTTLE This package is contained within the CARTON (54473-167-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090283	08/12/2010	10/01/2010

Labeler - Melaleuca, Inc. (139760102)

Revised: 02/2011Melaleuca, Inc.