RANITIDINE- ranitidine tablet 
RANITIDINE COOL MINT- ranitidine tablet 
Granules India Ltd

----------

Ranitidine Tablets

ACTIVE INGREDIENT(S)

Ranitidine 150 mg



PURPOSE

Acid reducer 

USE(S)

◾ 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

ASK A DOCTOR BEFORE USE IF

◾ 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 DOCTOR IF

◾ your heartburn continues or worsens
◾ you need to take this product for more than 14 days

PREGNANCY/BREASTFEEDING

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 (for cool mint tablets only)

◾ children under 12 years: ask a doctor

OTHER INFORMATION

◾ do not use if individual blister unit is open or torn.

◾ do not use if printed foil under bottle cap is open or torn

◾ store at 20 0-25 0​C (68 0​-77 0​F)

◾ avoid excessive heat or humidity

◾ this product is sodium and sugar free

INACTIVE INGREDIENTS

For 150 mg:croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,talcum, titanium dioxide

For 150 mg cool mint:acacia, croscarmellose sodium, FD&C Blue No. 1,magnesium stearate, menthol, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, talcum,
titanium dioxide

Questions or comments?

•Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM EST.

This product is not manufactured or distributed by Boehringer Ingelheim ® consumer health care products, distributor of Zantac 150mg and 150mg Cool Mint

Read the directions and warnings before use.

Keep the carton. It contains important information including tips for managing heartburn.

Tips for managing heartburn

•Do not lie flat or bend over soon after eating


•Do not eat late at night, or just before bedtime


•Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty andfried foods, chocolate, caffeine, alcohol, even some fruits and vegetables.


•Eat slowly and do not eat big meals


•if you are overweight, lose weight


•if you smoke, quit smoking


•Raise the head of your bed


•Wear loose fitting clothing around your stomach

PRINCIPAL DISPLAY PANEL

62207-774-58-carton.jpg62207-774-47-carton.jpg62207-774-41-carton.jpg62207-773-58-carton.jpg62207-773-47-carton.jpg62207-773-41-carton.jpgranitidine-label4-jpgranitidine-label3-jpgranitidine-150mg-label2-jpgranitidine-150mg-label1-jpg62207-774-32.jpg62207-773-32.jpg62207-774-336.jpg62207-773-36-carton.jpg

RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-773
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 150;G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-773-582 in 1 CARTON06/26/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:62207-773-411 in 1 CARTON06/26/2019
224 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:62207-773-471 in 1 CARTON06/26/2019
3500 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:62207-773-365 in 1 CARTON06/26/2019
4NDC:62207-773-3210000 in 1 BAG; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21024306/26/2019
RANITIDINE  COOL MINT
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-774
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorMINTImprint Code 150;G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-774-582 in 1 CARTON06/26/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:62207-774-411 in 1 CARTON06/26/2019
224 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:62207-774-471 in 1 CARTON06/26/2019
3500 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:62207-774-365 in 1 CARTON06/26/2019
410000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21024306/26/2019
Labeler - Granules India Ltd (915000087)

Revised: 1/2023
Document Id: f33bf0be-f52e-a8c3-e053-2a95a90a033a
Set id: aab81d9f-397d-49fb-8083-77a1872cc71f
Version: 9
Effective Time: 20230127
 
Granules India Ltd