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  5. Label Information: Zantac 75

FDA Label for Zantac 75

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. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?
    11. OTHER
    12. HOW SUPPLIED

Zantac 75 Product Label

The following document was submitted to the FDA by the labeler of this product Carilion Materials Management. 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
Ranitidine 75 mg (as ranitidine hydrochloride 84 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 foods and beverages

Warnings



Allergy alert: Do not use if you are allergic to ranitidine 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

    • If pregnant or breast-feeding, ask a health professional before use.


Directions



  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water
    • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
    • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
    • do not chew tablet
    • children under 12 years: ask a doctor

Other Information



  • do not use if printed foil under bottle cap is open or torn (bottles)
  • do not use if individual blister unit is open or torn (blisters)
  • do not use if individual foil packet is open or torn (pouch)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive Ingredients



hypromellose, magnesium stearate, microcrystalline cellulose, iron oxide, titanium dioxide, triacetin


Questions?



call 1-888-285-9159 (English/Spanish) M – F, 8:30 – 5 EST, or visit www.zantacotc.com


Other



Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products
Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877
© 2016, BI Pharmaceuticals, Inc. All rights reserved.
Product of Spain. Manufactured in Mexico.


How Supplied



Product: 68151-2584

NDC: 68151-2584-0 1 TABLET, COATED in a PACKAGE


* Please review the disclaimer below.