![ACID REDUCER 150 (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP]](https://medic.hrt.org//dailymed/images/612f1f76-034e-8161-e053-2991aa0ab4d8/gc770.jpg)
| NDC | 57896-770-05, 57896-770-24, 57896-770-65 |
| Set ID | 612f1f76-034e-8161-e053-2991aa0ab4d8 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | GERI-CARE PHARMACEUTICAL CORP |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA200172 |
- Active ingredient (in each tablet)
- Purpose
- Uses
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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 supervision of a doctor
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
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Directions
- 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
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ACID REDUCER 150
ranitidine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-770 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 150 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) VANILLIN (UNII: CHI530446X) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color pink Score no score Shape ROUND Size 9mm Flavor Imprint Code APO;RAN150 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-770-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2014 2 NDC:57896-770-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2014 3 NDC:57896-770-65 65 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200172 11/01/2014 Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254) Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254) Establishment Name Address ID/FEI Business Operations Apotex Inc 209429182 manufacture(57896-770)
