ranitidine hydrochloride tablet

Drug Labeling and Warnings

Drug Details [pdf]

ACID REDUCER- ranitidine hydrochloride tablet, film coated 
Ohm Laboratories Inc.

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ranitidine hydrochloride tablet

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Acid reducer

INDICATIONS AND USAGE

  • 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.

OTC - 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).

DOSAGE AND ADMINISTRATION

  • 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

SPL UNCLASSIFIED

  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT 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 INGREDIENT

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

OTC - QUESTIONS

call 1-800-406-7984

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient of Zantac75®

ohm®

NDC: 51660-352-31

Regular Strength

Ranitidine Tablets, USP 75 mg

Acid Reducer

30 TABLETS

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Distributed by: Ohm Laboratories Inc.

5105582/1013

ohmrani
ACID REDUCER 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51660-352
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (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: 51660-352-301 in 1 CARTON07/10/201209/11/2019
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 51660-352-601 in 1 CARTON07/10/201209/11/2019
260 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 51660-352-311 in 1 CARTON07/10/201209/11/2019
330 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC: 51660-352-691 in 1 CARTON07/10/201209/11/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20174507/10/201209/11/2019
Labeler - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited915786829MANUFACTURE(51660-352)

Revised: 9/2019
Document Id: 98611459-11ca-4915-b9f0-ebfee60602f7
Set id: d0f480dd-4680-4b83-a40e-455fb9d8b109
Version: 3
Effective Time: 20190911
 
Ohm Laboratories Inc.