NDC | 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-68, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87 |
Set ID | 888d9feb-fc9b-49cc-8361-30b5da86ea05 |
Category | HUMAN OTC DRUG LABEL |
Packager | Boehringer Ingelheim Pharmaceuticals Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NDA021698 |
- Drug Facts
- Uses
-
Warnings
Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers
- 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 and 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
- Stop use and ask a doctor if
-
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)
- do not chew tablet
- children under 12 years: ask a doctor
- adults and children 12 years and over:
- Other information
- INACTIVE INGREDIENT
-
QUESTIONS
Questions? call 1-888-285-9159 (English/Spanish) M – F, 8:30 – 5 EST, or visit www.zantacotc.com
Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.
Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products
Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877
© 2016, BI Pharmaceuticals, Inc. All rights reserved.
Product of Spain. Manufactured in Mexico. - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZANTAC MAXIMUM STRENGTH 150 COOL MINT
ranitidine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0120 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) hypromelloses (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) polyethylene glycols (UNII: 3WJQ0SDW1A) polysorbate 80 (UNII: 6OZP39ZG8H) sucralose (UNII: 96K6UQ3ZD4) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape PENTAGON (5 sided) Size 4mm Flavor MINT Imprint Code Z;150 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0597-0120-06 1 in 1 CARTON 1 3 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0597-0120-08 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0597-0120-09 4 in 1 CARTON 3 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0597-0120-24 3 in 1 CARTON 4 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:0597-0120-38 1 in 1 CARTON 5 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:0597-0120-50 1 in 1 CARTON 6 50 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0597-0120-68 1 in 1 CARTON 7 65 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0597-0120-80 80 in 1 CARTON 8 1 in 1 POUCH; Type 0: Not a Combination Product 9 NDC:0597-0120-82 80 in 1 CARTON 9 1 in 1 POUCH; Type 0: Not a Combination Product 10 NDC:0597-0120-87 1 in 1 CARTON 10 85 in 1 BOTTLE; Type 0: Not a Combination Product 11 NDC:0597-0120-78 1 in 1 CARTON 11 78 in 1 BOTTLE; Type 0: Not a Combination Product 12 NDC:0597-0120-76 2 in 1 CARTON 12 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021698 12/21/2006 Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944) Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944) Establishment Name Address ID/FEI Business Operations Patheon Manufacturing Services LLC 079415560 MANUFACTURE(0597-0120) Establishment Name Address ID/FEI Business Operations Boehringer Ingelheim Promeco S.A de C.V. 812579472 LABEL(0597-0120) , PACK(0597-0120) , MANUFACTURE(0597-0120) , ANALYSIS(0597-0120)