Zantac Cool Mint

Pronunciation

Generic Name: ranitidine
Dosage Form: tablet, coated

Zantac Drug Facts

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 certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use

  • with other acid reducers
  • if you have kidney disease, except under the advice and supervision of a doctor
  • 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.

Ask a doctor before use if you have

  • nausea or vomiting
  • stomach pain
  • unexplained weight loss
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • 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

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

  • Blister: do not use if individual blister unit is open or torn
    Bottle: do not use of printed foil under bottle cap is open or torn
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

carrageenan, FD&C blue no.1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,polysorbate, sucralose, and titanium dioxide

Questions?     call 1-888-285-9159 or visit www.zantacotc.com

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Dist: Boehringer Ingelheim Consumer Health Care Products Division of Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 ©2009

ZANTAC  150 COOL MINT TABLETS
ranitidine tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0120
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ranitidine hydrochloride (ranitidine) ranitidine hydrochloride 168 mg
Inactive Ingredients
Ingredient Name Strength
carrageenan  
FD&C Blue No. 1  
hypromellose  
magnesium stearate  
cellulose, microcrystalline  
polyethylene glycol  
polysorbate 80  
sucralose  
titanium dioxide  
Product Characteristics
Color BLUE (BLUE) Score no score
Shape PENTAGON (5 sided) Size 4mm
Flavor MINT (MINT) Imprint Code Z;150
Contains         
Packaging
# Item Code Package Description
1 NDC:0597-0120-24 3 BLISTER PACK (3 BLISTER PACK) in 1 BOX
1 8 TABLET, COATED (8 TABLET) in 1 BLISTER PACK
2 NDC:0597-0120-38 1 BLISTER PACK (1 BLISTER PACK) in 1 BOX
2 8 TABLET, COATED (8 TABLET) in 1 BLISTER PACK
3 NDC:0597-0120-50 1 BOTTLE (1 BOTTLE) in 1 BOX
3 50 TABLET, COATED (50 TABLET) in 1 BOTTLE
4 NDC:0597-0120-68 1 BOTTLE (1 BOTTLE) in 1 BOX
4 65 TABLET, COATED (65 TABLET) in 1 BOTTLE
5 NDC:0597-0120-87 1 BOTTLE (1 BOTTLE) in 1 BOX
5 85 TABLET, COATED (85 TABLET) in 1 BOTTLE
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)
Establishment
Name Address ID/FEI Operations
DSM Pharmaceuticals 076301910 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Promeco S.A de C.V. 812579472 MANUFACTURE
Revised: 05/2009
 
Boehringer Ingelheim Pharmaceuticals, Inc.



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