RANITIDINE- ranitidine tablet 
Dr. Reddy's Laboratories Limited

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Drug Facts

Active ingredient (in each tablet)

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

Purpose

Acid reducer

Uses

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
  • kidney disease

Ask a doctor or pharmacist before use if you are

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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

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

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Ranitidine Tablets USP, 75 mg - container label

container

Ranitidine Tablets USP, 75 mg - Container CartonLabel

containercarton

RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-131
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)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
ferrosoferric oxide (UNII: XM0M87F357)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize7mm
FlavorImprint Code P75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-131-301 in 1 CARTON03/01/2000
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55111-131-601 in 1 CARTON03/01/2000
260 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55111-131-801 in 1 CARTON03/01/2000
380 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55111-131-901 in 1 CARTON03/01/2000
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:55111-131-041 in 1 CARTON03/01/2000
5120 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:55111-131-371 in 1 CARTON03/01/2000
6160 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:55111-131-791 in 1 CARTON03/01/2000
710 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:55111-131-142 in 1 CARTON03/01/2000
810 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC:55111-131-813 in 1 CARTON03/01/2000
910 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:55111-131-451 in 1 CARTON03/01/2000
1045 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07529403/01/2000
Labeler - Dr. Reddy's Laboratories Limited (650562841)

Revised: 5/2019
Document Id: 654a9ddb-f441-a17a-f8ae-633148d041c8
Set id: 12a38e29-130c-6d41-1753-acccb0b41efe
Version: 10
Effective Time: 20190502
 
Dr. Reddy's Laboratories Limited