Famotidine Tablet, Film Coated
FDA Label NDC 55319-409

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar for the product Famotidine (NDC 55319-409). 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.

Label Section Quick Index

Other

Drug Facts

Distributed by: MIDWOOD BRANDS, LLC

500 Volvo Pkwy, Chesapeake, Va 23320 USA
Product of India
M.L. No.: 02/SKL/AP/2015/F/R

Revision: 06/25

Active Ingredient (In Each Tablet)

Famotidine, USP 10 mg and 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

  • 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
  • kidney disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking 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 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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
    • to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
    • 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 the carton. It contains important information.
  • store at 20°C to 25°C (68°F to 77°F)
  • protect from moisture

Inactive Ingredients

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol

Questions Or Comments?

Call us at 1 (888) 721-7115 (toll-free)

Principal Display Panel

NDC 55319-408-01

Famotidine Tablets, USP 10mg

60 Tablets

Carton10mg60 (Carton10mg60)

Carton10mg60 (Carton10mg60)

NDC 55319-409-03

Famotidine Tablets, USP 20mg

100 Tablets

Carton20mg100 (Carton20mg100)

Carton20mg100 (Carton20mg100)

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