Famotidine Tablet, Film Coated
FDA Label NDC 49035-589

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Famotidine (NDC 49035-589). 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, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other


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


  • 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  

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

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 (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 15 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
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)
  • protect from moisture

Inactive Ingredients


carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc and titanium dioxide.

Questions Or Comments?


call 1-888-287-1915

Tips for Managing Heartburn

 

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

    • JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

    Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

    Distributed by:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Made in India
    Code: TS/DRUGS/22/2009


Package Label-Principal Display Panel -10 Mg (90 Tablets Container Label)

AUROHEALTH

NDC 49035-589-19
See New Warnings
ORIGINAL STRENGTH
Famotidine
Tablets USP 10 mg
Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion  

90 Tablets   

Package Label-principal Display Panel -10 mg (90 Tablets Container Label) (Famotidine Fig1)

Package Label-principal Display Panel -10 mg (90 Tablets Container Label) (Famotidine Fig1)


Package Label-Principal Display Panel -10 Mg (90 Tablets Container Carton Label)

AUROHEALTH
NDC 49035-589-19
See New Warnings
*Compare to the Active Ingredient
of Original Strength Pepcid® AC
ORIGINAL STRENGTH
Famotidine
Tablets USP 10 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

90 Tablets

Famotidine-fig2.jpg (Famotidine Fig2)

Famotidine-fig2.jpg (Famotidine Fig2)




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