RxNorm Names
Review RxNorm Normal Forms
RANITIDINE - ACID REDUCER
(ranitidine)
tablet
[Ohm Laboratories Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ed9341a-38a9-4d0c-bf48-882a1b4a35c5| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
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
- 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
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. (for Bottle Cartons/Labels only)
- TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for Stand Alone Label and Extended Labels only)
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. (for Blister Cartons only)
- 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, talc, titanium dioxide
QUESTIONS?
Read the directions, consumer information leaflet and warnings before use.
PRINCIPAL DISPLAY PANEL
Ranitidine Tablets, USP 150 mg
Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach
†Compare to the active ingredient of Zantac 150®
†This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals Inc., owner of the registered trademark Zantac 150®
| RANITIDINE - ACID REDUCER
ranitidine tablet |
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| Labeler - Ohm Laboratories Inc. (184769029) |
| Registrant - Ohm Laboratories Inc. (184769029) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Shasun Pharmaceuticals Limited | 915786829 | manufacture(51660-351) | |
Revised: 07/2012
Document Id: 8434cef5-af69-475b-a99d-497b59cbd144
Set id: 5ed9341a-38a9-4d0c-bf48-882a1b4a35c5
Version: 2
Effective Time: 20120718
Ohm Laboratories Inc.
