Label: GOOD SENSE ACID REDUCER- ranitidine hydrochloride tablet
- NDC Code(s): 63629-4663-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0113-0271
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
If you are a consumer or patient please visit this version.
- Active ingredient (in each tablet)
Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)Close
- 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
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- do not use if printed foil under cap is broken or missing
- store at 20° - 25°C (68° - 77°F)
- avoid excessive heat or humidity
- this product is sugar free
- Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.Close
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
Ranitidine 75mg TabletClose
- INGREDIENTS AND APPEARANCE
GOOD SENSE ACID REDUCER
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-4663(NDC:0113-0271) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 75 mg Product Characteristics Color PINK Score no score Shape HEXAGON (6 sided) Size 8mm Flavor Imprint Code W75 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-4663-1 60 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076760 05/21/2009 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-4663) , RELABEL(63629-4663)