Famotidine Tablet, Film Coated
FDA Label NDC 58602-829

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Famotidine (NDC 58602-829). 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 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, 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

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


  • 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 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
  • 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, titanium dioxide and yellow iron oxide.

Questions Or Comments?


call 1-855-274-4122

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
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

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


Package Label-Principal Display Panel -20 Mg (85 Tablets, Container Label)

NDC 58602-829-50
PrimaryHealth
See New Warnings
Acid Reducer
MAXIMUM STRENGTH
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

85 Tablets

Package Label-principal Display Panel -20 mg (100 Tablets, Container Label) (Famotidine 20mg Fig1)

Package Label-principal Display Panel -20 mg (100 Tablets, Container Label) (Famotidine 20mg Fig1)





Package Label-Principal Display Panel -20 Mg (85 Tablets, Container Carton Label)

NDC 58602-829-50
PrimaryHealth
*COMPARE TO Maximum
Strength Pepcid® AC
Active Ingredient
See New Warnings
MAXIMUM STRENGTH
Acid Reducer
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion
Actual Size
85 Tablets

Package Label-principal Display Panel -20 mg (100 Tablets, Container Carton Label) (Famotidine 20mg Fig2)

Package Label-principal Display Panel -20 mg (100 Tablets, Container Carton Label) (Famotidine 20mg Fig2)







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