Ranitidine by Major Pharmaceuticals / Ranbaxy Pharmaceuticals Inc. / Shasun Pharmaceuticals Limited Drug Facts

Ranitidine by

Drug Labeling and Warnings

Ranitidine by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Ranbaxy Pharmaceuticals Inc., Shasun Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RANITIDINE- ranitidine tablet, film coated 
Major Pharmaceuticals

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 mg)

PURPOSE

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

  • 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 (1-800-222-1222).

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

  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER 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

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

MAJOR

NDC: 0904-6349-46

REGULAR STRENGTH

RANITIDINE 75

Ranitidine Tablets, USP 75 mg

Acid Reducer

Prevents and Relieves Heartburn associated with Acid Indigestion and Sour Stomach

COMPARE TO the active ingredient of ZANTAC 75®*

30 Tablets

Distributed By MAJOR® PHARMACEUTICALS

5104397/0813

Rani75
RANITIDINE 
ranitidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0904-6349
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code OR;606
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0904-6349-461 in 1 CARTON10/01/201311/30/2019
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 0904-6349-521 in 1 CARTON10/01/201309/30/2019
260 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20174510/01/201311/30/2019
Labeler - Major Pharmaceuticals (191427277)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Shasun Pharmaceuticals Limited915786829manufacture(0904-6349)

Revised: 11/2018
Document Id: 4f0084e3-f200-41a4-838e-556e7017a38d
Set id: b4a11507-0960-4007-b86a-ba449228d3f2
Version: 2
Effective Time: 20181119
 
Major Pharmaceuticals