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Berkley and Jensen Acid Controller Maximum Strength Prescribing Information

Package insert / product label
Generic name: famotidine
Dosage form: tablet
Drug class: H2 antagonists

Medically reviewed by Drugs.com. Last updated on Jun 21, 2022.

Active ingredient (in each tablet)

Famotidine 20 mg

Purpose

Acid reducer

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 food and beverages

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.
  • if you have kidney disease, except under the advice and supervision of a 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

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:
  • 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 at any time 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

Other information

  • read the directions and warnings before use
  • keep all packaging. It contains important information. {STRETCH CARD CONFIGURATION ONLY}
  • store at 20°-25°C (68°-77°F)
  • protect from moisture and light

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide

Questions or comments?

1-800-934-1204

Principal Display Panel

Compare to the active ingredient in Maximum Strength Pepcid® AC

Maximum Strength

Acid Controller

Famotidine Tablets, 20 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Actual Size

Acid Controller Tablets Stretch Card

BERKLEY AND JENSEN ACID CONTROLLER MAXIMUM STRENGTH
famotidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-194
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 8mm
Flavor Imprint Code L194
Contains
Packaging
# Item Code Package Description
1 NDC:68391-194-78 2 BOTTLE (BOTTLE) in 1 PACKAGE
1 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077351 11/08/2006
Labeler - BJWC (159082692)
BJWC

Frequently asked questions

Medical Disclaimer