MAXIMUM STRENGTH RANITIDINE - ranitidine tablet 
Aurohealth LLC

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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, and fried 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

Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride USP 167.414 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

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 (1-800-222-1222) 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

 

  • TAMPER EVIDENT: Do Not Use If The Carton Or Printed Foil Under Cap Is Open or Torn
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat or humidity
  • this product is sugar free
  • USP Dissolution Test Pending.

Inactive ingredients

croscarmellose sodium, FD&C Blue No.1, hypromellose, magnesium stearate, microcrystalline cellulose, N & A MINT FL, sucralose, titanium dioxide and triacetin

Questions?

call 1-855-274-4122

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (65's Tablet Bottle)

AUROHEALTH

NDC 58602-740-16
MAXIMUM STRENGTH
Ranitidine Tablets USP, 150 mg
COOL MINT TABLETS
ACID REDUCER
PREVENTS & RELIEVES HEARTBURN

associated with acid indigestion
and sour stomach
Sugar Free
RELEASES A COOLING SENSATION IN
MOUTH & THROAT
65 TABLETS (65 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (65's Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (65's Tablets Bottle Carton)


AUROHEALTH

NDC 58602-740-16

*Compare to the active

ingredient in Zantac 150® Cool Mint
MAXIMUM STRENGTH
Ranitidine
Tablets USP,
150 mg

COOL MINT TABLETS
ACID
REDUCER

Sugar Free
PREVENTS & RELIEVES
HEARTBURN
associated withacid
indigestion and sour stomach

RELEASES A COOLING SENSATION IN
MOUTH & THROAT
65 TABLETS (65 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (65's Tablets Bottle Carton)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Blister Carton (24's (3 x 8) Tablets)

AUROHEALTH

NDC 58602-740-72
*Compare to the active

Ingredient in Zantac 150® Cool Mint


MAXIMUM STRENGTH
Ranitidine
Tablets USP,
150 mg
COOL MINT TABLETS
ACID
REDUCER
Sugar Free
PREVENTS & RELIEVES
HEARTBURN
associated with acid
indigestion and sour stomach
RELEASES A COOLING SENSATION IN
MOUTH & THROAT
24 TABLETS (24 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Blister Carton (24's (3 x 8) Tablets)

MAXIMUM STRENGTH RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-740
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINT (UNII: FV98Z8GITP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize8mm
FlavorMINTImprint Code K;49
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-740-161 in 1 CARTON11/13/201707/08/2021
165 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-740-201 in 1 CARTON11/13/201707/08/2021
295 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-740-723 in 1 CARTON11/13/201707/08/2021
3NDC:58602-740-798 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20757811/13/201707/08/2021
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-740) , MANUFACTURE(58602-740)

Revised: 7/2021
 
Aurohealth LLC