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 Shopko Stores Operating Co., 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.
Active Ingredient (In Each Tablet)
Ranitidine 150 mg (as ranitidine hydrochloride 168 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 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
- if you have kidney disease, except under the advice and supervision of a doctor
Ask A Doctor Before Use If You Have:
- frequent chest pain
- unexplained weight loss
- 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
- frequent wheezing, particularly with heartburn
- nausea or vomiting
Stop Use And Ask A Doctor If
- your heartburn continues or worsens
- stomach pain continues
- you need to take this product for more than 14 days
If Pregnant Or Breast-Feeding,
Ask a health care professional before use.
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 older:
- 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 of age: ask a doctor
Other Information
- do not use if printed foil under cap is torn or open
- store at controlled room temperature 20°-25°C (68°-77°F)
- avoid excessive heat or humidity
- this product is sugar free
- *This product is not manufactured or distributed by Glaxosmithkline Consumer Healthcare, owner of the registered trademark Zantac® 150
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C yellow # 6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.
Principal Display Panel
SHOPKO®
Maximum Strength HEARTBURN
Ranitidine Tablets, USP 150 mg
Acid Reducer
One tablet relieves: heartburn, acid indigestion & sour stomach
*Compare to Zantac 150® active ingredient
Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.
Packaged by:
PL Developments
200 Hicks street
Westbury, NY 11590, USA
Questions or comments?
call toll free 1-877-753-3935
Product of INDIA
Product Label
Ranitidine 150 mg
* Please review the disclaimer below.