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 packet is open or torn (pouch)
  • store at 20º-25ºC (68º-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, 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.

Boehringer Ingelheim Consumer Health Care Products
Division of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
Copyright © 2014, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.
Product of Spain. Manufactured in Mexico.

Zantac 150 mg Cool Mint - 24 Count Blister Carton

Zantac 150 mg Cool Mint - 65 Count Bottle 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
carrageenan 
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: 08/2014
 
Boehringer Ingelheim Pharmaceuticals Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)