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Zantac 75 by Boehringer Ingelheim Pharmaceuticals Inc.

Dosage form: tablet, coated
Ingredients: ranitidine hydrochloride 75.000mg
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 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

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)
  • 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

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

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 75mg - 30ct 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) ranitidine75.000 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:0597-0122-811 BOTTLE in 1 CARTON
180 TABLET, COATED in 1 BOTTLE
2NDC:0597-0122-921 BOTTLE in 1 CARTON
2105 TABLET, COATED in 1 BOTTLE
3NDC:0597-0122-404 BLISTER PACK in 1 CARTON
310 TABLET, COATED in 1 BLISTER PACK
4NDC:0597-0122-131 BLISTER PACK in 1 CARTON
410 TABLET, COATED in 1 BLISTER PACK
5NDC:0597-0122-373 BLISTER PACK in 1 CARTON
510 TABLET, COATED in 1 BLISTER PACK
6NDC:0597-0122-61100 POUCH in 1 CARTON
61 TABLET, COATED in 1 POUCH
7NDC:0597-0122-272 BLISTER PACK in 1 CARTON
710 TABLET, COATED in 1 BLISTER PACK
8NDC:0597-0122-341 BLISTER PACK in 1 CARTON
84 TABLET, COATED in 1 BLISTER PACK
9NDC:0597-0122-541 BOTTLE in 1 CARTON
960 TABLET, COATED in 1 BOTTLE
10NDC:0597-0122-961 BOTTLE in 1 CARTON
1096 TABLET, COATED in 1 BOTTLE
11NDC:0597-0122-57100 POUCH in 1 CARTON
111 TABLET, COATED in 1 POUCH
12NDC:0597-0122-081 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
Boehringer Ingelheim Promeco S.A. de C.V.812579472LABEL(0597-0122), MANUFACTURE(0597-0122), PACK(0597-0122), ANALYSIS(0597-0122)
Establishment
NameAddressID/FEIOperations
Patheon Manufacturing Services LLC079415560MANUFACTURE(0597-0122)

Revised: 07/2014
 
Boehringer Ingelheim Pharmaceuticals Inc.

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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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