Berkley and Jensen Acid Controller Complete

Dosage Form: tablet
BJWC Acid Controller 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, D&C red no. 7 calcium, dextrates, FD&C blue no. 1 lake, FD&C red no. 40 lake, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions or comments?

1-800-934-1204

Principal Display Panel

Dual Action

Acid Controller

Complete

Famotidine 10 mg, Calcium Carbonate 800 mg, Magnesium Hydroxide 165 mg Tablets

Acid Reducer + Antacid

Just One Tablet Relieves Heartburn Due to Acid Indigestion

Berry Flavor

Acid Controller Label

BERKLEY AND JENSEN ACID CONTROLLER  COMPLETE famotidine, calcium carbonate and magnesium hydroxide  tablet, chewable

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68391-321 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK (mottled) Score no score Shape ROUND (bi-layered) Size 17mm Flavor BERRY Imprint Code L321 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68391-321-76 120 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077355	07/08/2009

Labeler - BJWC (159082692)

Revised: 05/2009BJWC

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