RANITIDINE- ranitidine hydrochloride tablet, film coated 
H-E-B

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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)
    • Do not chew tablet
  • children under 12 years: ask a doctor

Other information

  • do not use if seal under bottle cap is broken or missing (bottles)
  • do not use if individual blister unit is open or torn (blisters)
  • 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, cool vanilla mint flavor, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide

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

Cool Mint Tablets

Maximum Strength

Acid Reducer

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

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Releases a Cooling Sensation in Mouth & Throat

Sugar Free

Distributed by: HEB

ranitidineCLMT-150-24btl.jpg

PRINCIPAL DISPLAY PANEL

Cool Mint Tablets

Maximum Strength

Acid Reducer

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

Prevents & Relieves Heartburn

Associated with Acid Indigestion & Sour Stomach

Releases a Cooling Sensation in Mouth & Throat

Sugar Free

Distributed by: HEB

ranitidineCLMT-150-24ctn.jpg

RANITIDINE 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-303
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)  
Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize9mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-303-021 in 1 CARTON01/25/201806/14/2022
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20017201/25/201806/14/2022
Labeler - H-E-B (007924756)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc209429182analysis(37808-303) , manufacture(37808-303)

Revised: 6/2022
Document Id: 37439e58-1128-8cd8-613a-aa3e4bb0f413
Set id: d1f39d44-9fed-e72c-9011-d153bbfce894
Version: 2
Effective Time: 20220614
 
H-E-B