FDA Label for Ranitidine
View Indications, Usage & Precautions
Ranitidine Product Label
The following document was submitted to the FDA by the labeler of this product Health 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.
Active Ingredient (In Each Tablet)
Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 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 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
- frequent chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- 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
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 right away (1-800-222-1222).
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)
- children under 12 years: ask a doctor
Other Information
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.
- store at 20° - 25° C (68° - 77° F)
- avoid excessive heat or humidity
- this product is sodium and sugar free
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide
Questions?
Call 1-800-406-7984
Principal Display Panel
NDC 62011-0225-2
HealthMart®
PHARMACY
compare to Zantac 75®active ingredient†
ranitidine tablets, USP 75 mg
acid reducer
prevents and relieves heartburn associated with acid indigestion and sour stomach
regular strength
60 tablets
Distributed by McKesson
5104343/0713
* Please review the disclaimer below.