Berkley and Jensen Acid Controller Complete

Generic Name: famotidine, calcium carbonate and magnesium hydroxide
Dosage Form: tablet

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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	Item Code (Source)	NDC: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

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

Packaging
#	Item Code	Package Description
1	NDC:68391-321-76	120 TABLET, CHEWABLE (TABLET) in 1 BOTTLE

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

Labeler - BJWC (159082692)

Revised: 05/2009

BJWC

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