Label: ACID REDUCER- ranitidine tablet, film coated
Contains inactivated NDC Code(s)
NDC Code(s): 68071-5012-3
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 57896-715
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 19, 2021
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
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
- 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 chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- do not chew tablet
- swallow tablet with a glass of water
- adults and children 12 years and over:
- to relieve symptoms, take 1 tablet
- to prevent symptoms, take 1 tablet 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
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
ranitidine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-5012(NDC:57896-715) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 75 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color pink Score no score Shape ROUND Size 7mm Flavor Imprint Code P75 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-5012-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075294 10/01/2018 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-5012)