RANITIDINE- ranitidine tablet, coated 
Chain Drug Marketing Association

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Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

Purpose

Acid reducer

Use(s)

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
  • if you have kidney disease, except under the advice and supervision of a doctor

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 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

Other information

Inactive ingredients

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

Call 1-888-375-3784

Carton Label

Carton

Bottle label

Bottle


RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-480(NDC:55111-404)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ranitidine Hydrochloride (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
magnesium stearate (UNII: 70097M6I30)  
cellulose, microcrystalline (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize9mm
FlavorImprint Code R150
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-480-501 in 1 CARTON07/01/201809/30/2019
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:63868-480-241 in 1 CARTON07/01/201809/30/2019
224 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07819207/01/2018
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Dr. Reddy's Laboratories Limited (650562841)

Revised: 9/2019
Document Id: 28939ea0-3aaa-0f2b-3adf-fdef8f40fd54
Set id: 7dc77beb-15c0-3543-f30d-7af8408e0dae
Version: 2
Effective Time: 20190930
 
Chain Drug Marketing Association