ACID REDUCER- ranitidine tablet, film coated 
NuCare Pharmaceuticals,Inc.

----------

GC765D

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

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 healthcare 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 1-800-540-3765

Principal Display Panel

pdp

ACID REDUCER 
ranitidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-5012(NDC:57896-715)
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize7mm
FlavorImprint Code P75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-5012-330 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07529410/01/2018
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-5012)

Revised: 2/2021
Document Id: bbb32fa7-604b-5010-e053-2a95a90ae159
Set id: 8f1358aa-4959-23da-e053-2995a90aa430
Version: 2
Effective Time: 20210219
 
NuCare Pharmaceuticals,Inc.