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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. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 MG (30 TABLETS CONTAINER LABEL)
    17. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 MG (30 TABLETS CONTAINER CARTON LABEL)

Famotidine Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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 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 1-855-274-4122
 

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.

    Dist. by CAH, Dublin, OH 43017                       
    1-800-200-6313
    ©2020 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal
    Health.
    Made in India
    Code: TS/DRUGS/22/2009



Package Label-Principal Display Panel -10 Mg (30 Tablets Container Label)



LEADERTM

NDC 70000-0048-1
Original Strength
Acid Reducer
Famotidine Tablets USP, 10 mg | Acid Reducer

Just One Tablet!
Prevents & Relieves
Heartburn Due to Acid Indigestion  

30 TABLETS                                    100% Money
SEE NEW WARNINGS             Back Guarantee



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 (30 Tablets Container Carton Label)



LEADERTM

NDC 70000-0048-1
Original Strength
Acid
Reducer
Famotidine Tablets USP, 10 mg
Acid Reducer

Just One Tablet!
Prevents & Relieves Heartburn
Due to Acid Indigestion  

Actual Size                                 COMPARE TO
                                                     ORIGINAL
                                                     STRENGTH
                                                     PEPCID® AC
                                                     active ingredient

30
TABLETS                                    100% Money
SEE NEW WARNINGS             Back Guarantee

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Carton Label) - famotidine fig2

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Carton Label) - famotidine fig2





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