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Zantac 75

Dosage form: tablet, coated
Ingredients: ranitidine hydrochloride 75mg
Labeler: Boehringer Ingelheim Pharmaceuticals Inc.
NDC Code: 0597-0122

Zantac 75® Drug Facts

Drug Facts
Active ingredient (in each tablet)Purpose
Ranitidine 75 mg (as ranitidine hydrochloride 84 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
  • 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

Ask a doctor before use if you have
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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)
  • 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 if printed foil under bottle cap is open or torn
  • store at 20º-25ºC (68º-77ºF)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Questions?

Call 1-888-285-9159 or visit www.zantacotc.com

Zantac 75mg - 20ct Blister Packs
NDC: 0597-0122-27

Zantac 75mg - 80 ct. Bottle
NDC: 0597-0122-81

ZANTAC 75 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0122
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ranitidine hydrochloride (ranitidine) ranitidine75 mg
Inactive Ingredients
Ingredient NameStrength
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
ferric oxide red 
titanium dioxide 
triacetin 
Product Characteristics
ColorPINKScoreno score
ShapePENTAGON (5 sided)Size3mm
FlavorImprint CodeZ;75
Contains    
Packaging
#Item CodePackage Description
1NDC:0597-0122-341 BLISTER PACK in 1 CARTON
14 TABLET, COATED in 1 BLISTER PACK
2NDC:0597-0122-541 BOTTLE in 1 CARTON
260 TABLET, COATED in 1 BOTTLE
3NDC:0597-0122-811 BOTTLE in 1 CARTON
380 TABLET, COATED in 1 BOTTLE
4NDC:0597-0122-921 BOTTLE in 1 CARTON
4105 TABLET, COATED in 1 BOTTLE
5NDC:0597-0122-081 TABLET, COATED in 1 POUCH
6NDC:0597-0122-404 BLISTER PACK in 1 CARTON
610 TABLET, COATED in 1 BLISTER PACK
7NDC:0597-0122-131 BLISTER PACK in 1 CARTON
710 TABLET, COATED in 1 BLISTER PACK
8NDC:0597-0122-272 BLISTER PACK in 1 CARTON
810 TABLET, COATED in 1 BLISTER PACK
9NDC:0597-0122-373 BLISTER PACK in 1 CARTON
910 TABLET, COATED in 1 BLISTER PACK
10NDC:0597-0122-57100 POUCH in 1 CARTON
101 TABLET, COATED in 1 POUCH
11NDC:0597-0122-61100 POUCH in 1 CARTON
111 TABLET, COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02052012/21/2006
Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Establishment
NameAddressID/FEIOperations
DSM Pharmaceuticals076301910MANUFACTURE(0597-0122)
Establishment
NameAddressID/FEIOperations
Boehringer Ingelheim Promeco S.A. de C.V.812579472LABEL(0597-0122), MANUFACTURE(0597-0122), PACK(0597-0122), ANALYSIS(0597-0122)

Revised: 04/2012
 
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.

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