Famotidine
FDA Label NDC 68210-0007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product Famotidine (NDC 68210-0007). 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, 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: Greenbrier International, Inc.
Chesapeake, VA 23320

Active Ingredient (In Each Tablet)

Famotidine USP 10mg

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

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.

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 25°-30°C (77°-86°F).
  • read the directions and warnings before use
  • protect from moisture.
  • keep the carton and package insert. They contain important information.

Inactive Ingredients

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

Questions Or Comments?

1-800-xxx-xxxx

Principal Display Panel - 12 Tablet Blister Pack Carton

ASSURED™

Compare to the
active ingredient
in Pepcid® AC*

Original Strength
HEARTBURN
RELIEF

FAMOTIDINE TABLETS USP, 10 mg

ACID REDUCER

Just One Tablet Relieves &
Prevents Heartburn Due to
Acid Indigestion

12 TABLETS (12 DOSES)

Principal Display Panel (12 Tablet Blister Pack Carton)

Principal Display Panel (12 Tablet Blister Pack Carton)

* Please review the disclaimer below.