ZANTAC 75- ranitidine tablet 
JC World Bell Wholesale Co., Inc.

----------

Zantac 75

​Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

​Purpose

Acid reducer

​Uses

  • relieves heartburn associated with acid indigestion and sour stomach
  • relieves 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 hertburn 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 individual foil pouch is open or torn
  • avoid excessive heat or humidity
  • store at 20 0-25 0C (68 0-77 0F)
  • this product is sodium and sugar free

​Inactive ingredients

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

Inactive ingredients

call 1-888-285-9159 (English/Spanish)M-F, 8:30-5 EST, or visit www.zantacotc.com for Tips for Managing Heartburn

​Package Labeling:

Label2

ZANTAC 75 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-222
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColororangeScoreno score
ShapePENTAGON (5 sided)Size7mm
FlavorImprint Code Z;75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50269-222-2525 in 1 BOX07/29/201611/01/2021
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02052007/29/201611/01/2021
Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Revised: 10/2021
Document Id: ceb957ce-9d0f-7d32-e053-2a95a90ad9b9
Set id: 1f79c236-966d-4398-aa4b-88d67967f78b
Version: 6
Effective Time: 20211019
 
JC World Bell Wholesale Co., Inc.