Famotidine: Package Insert and Label Information

FAMOTIDINE- famotidine tablet, film coated
Ohm Laboratories Inc.

Drug Facts

Active ingredient (in each tablet)

Famotidine, USP 10 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

  • with other acid reducers
  • 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.

Ask a doctor before use if you have

  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained 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 (1-800-222-1222).

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 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

  • 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.

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions?

call 1-800-406-7984

Distributed by:
Ohm Laboratories Inc.
1385 Livingston Avenue
North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Blister Pack Carton

†Compare to the active ingredient of
Original Strength Pepcid AC®
NDC 51660-035-31

ohm®

ORIGINAL STRENGTH
Acid Controller
Famotidine Tablets,
USP 10 mg
Acid Reducer

30 TABLETS

Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Blister Pack Carton
(click image for full-size original)
FAMOTIDINE
famotidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (1200000 MW)
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 035
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-035-31 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 30 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51660-035-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090283 02/15/2010
Labeler — Ohm Laboratories Inc. (184769029)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 manufacture (51660-035)

Revised: 08/2018 Ohm Laboratories Inc.

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