Famotidine Tablet
FDA Label NDC 37835-165

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Famotidine (NDC 37835-165). 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, allergy alert:, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

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

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

  • 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 wheezing, particularly with heartburn
  • frequent chest pain
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Acid reducers 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

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 (1-800-222-1222) 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
  • store at 20° - 25°C (68° - 77°F)
  • protect from moisture

Inactive Ingredients

Hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, polyethylene glycol, talc, titanium dioxide, triacetin.

Questions?

call toll-free 1-844-912-4012

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