RxNorm Names
Review RxNorm Normal Forms
RANITIDINE HYDROCHLORIDE tablet, film coated
[Select Brand]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ab60994a-9e23-4779-a05b-d708d57228b3| 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 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
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
| RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride tablet, film coated |
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
| Labeler - Select Brand (043562370) |
| Registrant - Ohm Laboratories Inc. (184769029) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Shasun Pharmaceuticals Limited | 915786829 | manufacture(15127-711) | |
Revised: 09/2012
Document Id: 2b36b3a0-e2a7-4db3-ba87-965e7c8f3086
Set id: ab60994a-9e23-4779-a05b-d708d57228b3
Version: 1
Effective Time: 20120928
Select Brand
