Famotidine
FDA Label NDC 46122-168

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Famotidine (NDC 46122-168). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By: AmerisourceBergen 1300 Morris Drive Chesterbrook, PA 19087

Active Ingredient (In Each Tablet)

Famotidine, USP 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

  • with other acid reducers
  • if you have kidney disease, except under the advice and supervision of a doctor
  • 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
  • stomach pain
  • unexplained weight loss
  • nausea or vomiting
  • frequent wheezing, particularly with heartburn
  • 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 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

  • store at 20° to 25° C (68° to 77° F)
  • protect from moisture
  • read the directions and warnings before use

Inactive Ingredients

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

Questions?

call 1-800-406-7984

Principal Display Panel - 20 Mg Tablet Bottle Label

GOOD
NEIGHBOR
PHARMACY®

NDC 46122-0168-78

†Compare to the active ingredient of
Maximum Strength Pepcid AC®

famotidine tablets, USP 20 mg

Acid Reducer

Maximum Strength

Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion

100 tablets

Principal Display Panel (20 mg Tablet Bottle Label)

Principal Display Panel (20 mg Tablet Bottle Label)

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