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Zantac Maximum Strength 150 Cool Mint

Dosage form: tablet, coated
Ingredients: ranitidine hydrochloride 150mg
Labeler: Boehringer Ingelheim Pharmaceuticals Inc.
NDC Code: 0597-0120

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 mg Cool Mint - 65 Count Carton

ZANTAC MAXIMUM STRENGTH 150 COOL MINT 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ranitidine hydrochloride (ranitidine) ranitidine150 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycols 
polysorbate 80 
sucralose 
titanium dioxide 
Product Characteristics
ColorBLUEScoreno score
ShapePENTAGON (5 sided)Size4mm
FlavorMINTImprint CodeZ;150
Contains    
Packaging
#Item CodePackage Description
1NDC:0597-0120-061 BLISTER PACK in 1 CARTON
13 TABLET, COATED in 1 BLISTER PACK
2NDC:0597-0120-081 TABLET, COATED in 1 POUCH
3NDC:0597-0120-094 BLISTER PACK in 1 CARTON
38 TABLET, COATED in 1 BLISTER PACK
4NDC:0597-0120-243 BLISTER PACK in 1 CARTON
48 TABLET, COATED in 1 BLISTER PACK
5NDC:0597-0120-381 BLISTER PACK in 1 CARTON
58 TABLET, COATED in 1 BLISTER PACK
6NDC:0597-0120-501 BOTTLE in 1 CARTON
650 TABLET, COATED in 1 BOTTLE
7NDC:0597-0120-681 BOTTLE in 1 CARTON
765 TABLET, COATED in 1 BOTTLE
8NDC:0597-0120-8080 POUCH in 1 CARTON
81 TABLET, COATED in 1 POUCH
9NDC:0597-0120-8280 POUCH in 1 CARTON
91 TABLET, COATED in 1 POUCH
10NDC:0597-0120-871 BOTTLE in 1 CARTON
1085 TABLET, COATED in 1 BOTTLE
11NDC:0597-0120-781 BOTTLE in 1 CARTON
1178 TABLET, COATED in 1 BOTTLE
12NDC:0597-0120-762 BLISTER PACK in 1 CARTON
128 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02169812/21/2006
Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Establishment
NameAddressID/FEIOperations
Patheon Manufacturing Services LLC079415560MANUFACTURE(0597-0120)
Establishment
NameAddressID/FEIOperations
Boehringer Ingelheim Promeco S.A de C.V.812579472LABEL(0597-0120), PACK(0597-0120), MANUFACTURE(0597-0120), ANALYSIS(0597-0120)

Revised: 12/2015
 
Boehringer Ingelheim Pharmaceuticals Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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