COMPLETE DUAL ACTION - famotidine, calcium carbonate and magnesium hydroxide tablet, chewable 
CVS Pharmacy

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CVS Pharmacy, Inc. Dual Action Complete Drug Facts

Active ingredient (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

Uses

relieves heartburn associated with acid indigestion and sour stomach

Warnings

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

Do not use

• 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.
• with other acid reducers

Ask a doctor before use if you have

• 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
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

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

• 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.

Directions

• adults and children 12 years and over:
• do not swallow tablet whole: chew completely
• to relieve symptoms, chew 1 tablet before swallowing
• do not use more than 2 chewable tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• each tablet contains: calcium 320 mg; magnesium 65 mg
• Phenylketonurics: Contains Phenylalanine 2.2 mg per tablet
• read the directions and warnings before use
• read the bottle label. It contains important information.
• store at 20°-25°C (68°-77°F)
• protect from moisture

Inactive ingredients

aspartame, dextrates, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, red iron oxide, sodium starch glycolate, talc

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients in Pepcid® Complete

Dual Action

Complete

Famotidine 10 mg/Calcium Carbonate 800 mg

Magnesium Hydroxide 165 mg Tablets

Acid Reducer plus Antacid

Just One Tablet

Relieves Heartburn Due to Acid Indigestion

Cool Mint Flavor

COMPLETE  DUAL ACTION famotidine, calcium carbonate, magnesium hydroxide   tablet, chewable

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 59779-546 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg CALCIUM CARBONATE (CARBONATE ION) CALCIUM CARBONATE 800 mg MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 165 mg

Inactive Ingredients Ingredient Name Strength ASPARTAME   DEXTRATES   GLYCERYL MONOSTEARATE   LACTOSE, ANHYDROUS   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYSORBATE 80   POVIDONE   STARCH, CORN   FERRIC OXIDE RED   SODIUM STARCH GLYCOLATE TYPE A POTATO   TALC

Product Characteristics Color ORANGE (PEACH WITH WHITE SPECKLES) Score no score Shape ROUND Size 18mm Flavor MINT Imprint Code L546 Contains

Packaging # NDC Package Description Multilevel Packaging 1 59779-546-63 25 TABLET In 1 BOTTLE None 2 59779-546-71 50 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077355	08/26/2008

Labeler - CVS Pharmacy (062312574)

Revised: 07/2009CVS Pharmacy