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
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- 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 LABEL 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 (RANITIDINE) 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)