ZANTAC MAXIMUM STRENGTH 150 COOL MINT- ranitidine tablet, coated 
Boehringer Ingelheim Pharmaceuticals Inc.

----------

Zantac 150® Cool Mint Tablets

Drug Facts

Active ingredient (in each tablet)Purpose
Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)..............................................................................................................................Acid reducer

Uses

  • 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

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 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

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

Other information

  • do not use if printed foil under bottle cap is open or torn (bottles)
  • do not use if individual blister unit is open or torn (blisters)
  • do not use if individual foil packet is open or torn (pouch)
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide

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.

Zantac 150 mg Cool Mint - 24 Count Carton

zantac-150-cool-mint-24ct

Zantac 150 mg Cool Mint - 65 Count Carton

zantac-150-cool-mint-65ct
ZANTAC MAXIMUM STRENGTH 150 COOL MINT 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ranitidine hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine150 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
hypromelloses (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
cellulose, microcrystalline (UNII: OP1R32D61U)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
sucralose (UNII: 96K6UQ3ZD4)  
titanium dioxide (UNII: 15FIX9V2JP)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorBLUEScoreno score
ShapePENTAGON (5 sided)Size4mm
FlavorMINTImprint Code Z;150
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0120-061 in 1 CARTON12/21/200610/18/2019
13 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0597-0120-081 in 1 POUCH; Type 0: Not a Combination Product12/21/200610/18/2019
3NDC:0597-0120-094 in 1 CARTON12/21/200610/18/2019
38 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0597-0120-243 in 1 CARTON12/21/200610/18/2019
48 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0597-0120-381 in 1 CARTON12/21/200610/18/2019
58 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:0597-0120-501 in 1 CARTON12/21/200610/18/2019
650 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0597-0120-681 in 1 CARTON12/21/200610/18/2019
765 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0597-0120-8080 in 1 CARTON12/21/200610/18/2019
81 in 1 POUCH; Type 0: Not a Combination Product
9NDC:0597-0120-8280 in 1 CARTON12/21/200610/18/2019
91 in 1 POUCH; Type 0: Not a Combination Product
10NDC:0597-0120-871 in 1 CARTON12/21/200610/18/2019
1085 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:0597-0120-781 in 1 CARTON12/21/200610/18/2019
1178 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:0597-0120-762 in 1 CARTON12/21/200610/18/2019
128 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02169812/21/200610/18/2019
Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Manufacturing Services LLC079415560MANUFACTURE(0597-0120)
Establishment
NameAddressID/FEIBusiness Operations
Boehringer Ingelheim Promeco S.A de C.V.812579472PACK(0597-0120) , ANALYSIS(0597-0120) , LABEL(0597-0120) , MANUFACTURE(0597-0120)

Revised: 5/2021
 
Boehringer Ingelheim Pharmaceuticals Inc.