RANITIDINE- ranitidine hydrochloride tablet, film coated 
Rite Aid Corporation

----------

Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 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
  • 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 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.

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

  • do not use if printed foil under bottle cap is broken or torn
  • store at 20°C to 25°C (68°F to 77°F)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

carnauba wax, colloidal silicon dioxide, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide and vanillin

Questions or Comments?

Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time) 

PRINCIPAL DISPLAY PANEL

Maximum Strength

Acid Reducer

Ranitidine Tablets USP, 150 mg - Bottle Label - 24 Tablets

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Distributed by: Rite Aid Corporation

ranitidine-150-24btl-riteaid.jpg

PRINCIPAL DISPLAY PANEL

Maximum Strength

Acid Reducer

Ranitidine Tablets USP, 150 mg - Carton Label - 24 Tablets

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Distributed by: Rite Aid Corporation

ranitidine-150-24ctn-riteaid.jpg

PRINCIPAL DISPLAY PANEL

Maximum Strength

Acid Reducer

Ranitidine Tablets USP, 150 mg - Bottle Label - 50 Tablets

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Distributed by: Rite Aid Corporation

ranitidine-150-50btl-riteaid.jpg

PRINCIPAL DISPLAY PANEL

Maximum Strength

Acid Reducer

Ranitidine Tablets USP, 150 mg - Carton Label - 50 Tablets

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Distributed by: Rite Aid Corporation

ranitidine-150-50ctn-riteaid.jpg

PRINCIPAL DISPLAY PANEL

Maximum Strength

Acid Reducer

Ranitidine Tablets USP, 150 mg - Bottle Label - 95 Tablets

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Distributed by: Rite Aid Corporation

ranitidine-150-95btl-riteaid.jpg

PRINCIPAL DISPLAY PANEL

Maximum Strength

Acid Reducer

Ranitidine Tablets USP, 150 mg - Carton Label - 95 Tablets

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Distributed by: Rite Aid Corporation

ranitidine-150-95ctn-riteaid.jpg

RANITIDINE 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6051
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine150 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
VANILLIN (UNII: CHI530446X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-6051-81 in 1 CARTON06/26/201704/30/2021
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20017206/26/201704/30/2021
RANITIDINE 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4727
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine150 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
VANILLIN (UNII: CHI530446X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-4727-31 in 1 CARTON06/26/201704/30/2021
195 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20017206/26/201704/30/2021
RANITIDINE 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6052
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine150 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
VANILLIN (UNII: CHI530446X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-6052-11 in 1 CARTON06/26/201704/30/2021
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:11822-6052-21 in 1 CARTON06/26/201704/30/2021
265 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20017206/26/201704/30/2021
Labeler - Rite Aid Corporation (014578892)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc209429182analysis(11822-6051, 11822-4727, 11822-6052) , manufacture(11822-6051, 11822-4727, 11822-6052)

Revised: 7/2020
Document Id: 392aa94f-085e-b542-cec7-c2e74b103a66
Set id: b91633d2-bbc6-a68b-ade8-194b30e084a7
Version: 3
Effective Time: 20200706
 
Rite Aid Corporation