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  5. Label Information: Famotidine

FDA Label for Famotidine

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. USES
    3. WARNINGS
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine Product Label

The following document was submitted to the FDA by the labeler of this product Wockhardt Usa Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active ingredient (in each tablet)                                                                        Purpose
Famotidine USP 10 mg ...............................................................................................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

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



  • read the directions and warnings before use
  • store at 25°-30°C (77°-86°F)
  • 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?



Call 1-800-346-6854Manufactured by:Wockhardt Limited,Mumbai, India.Distributed by:Wockhardt USA LLC.20 Waterview Blvd.Parsippany, NJ 07054 USA.Iss.100510

Package Label.Principal Display Panel






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