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  5. Label Information: Famotidine

FDA Label for Famotidine

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. ALLERGY ALERT:
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Famotidine Product Label

The following document was submitted to the FDA by the labeler of this product Bi-mart. 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.

Other



Drug Facts


Active Ingredient (In Each Tablet)



Famotidine 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

Allergy Alert:



Do not use if you are allergic to famotidine or other acid reducers.


Do Not Use



  • with other acid reducers
  • 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.

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 wheezing, particularly with heartburn
  • frequent chest pain
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you aretaking 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 (1-800-222-1222) right away. 


Directions



  • adults and children 12 years and over:
    • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating 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 20° - 25°C (68° - 77°F)
  • protect from moisture

Inactive Ingredients



Hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, polyethylene glycol, talc, titanium dioxide, triacetin.


Questions?



call toll-free 1-844-912-4012


Package Label-Principal Display Panel



label - label

label - label


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