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

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)
  • 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, hypromellose, magnesium stearate, microcrystalline cellulose, 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 (24 Tablets Bottle)

AUROHEALTH

NDC 58602-734-07
MAXIMUM STRENGTH
Ranitidine Tablets USP,
150 mg
ACID REDUCER
PREVENTS & RELIEVES
HEARTBURN
associated with
acid indigestion and sour stomach
24 TABLETS
(24 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (24 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (24's Tablets)


AUROHEALTH

NDC 58602-734-07
*Compare to the active
ingredient in Zantac 150®
MAXIMUM STRENGTH
Ranitidine
Tablets USP,
150 mg
ACID REDUCER
PREVENTS & RELIEVES
HEARTBURN
associated with
acid indigestion and sour stomach
 24 TABLETS
(24 DOSES)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (24's Tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Blister Carton (8's (1 x 8) Tablets)

AUROHEALTH

NDC 58602-734-79
*Compare to the active
ingredient in Zantac 150®
MAXIMUM STRENGTH
Ranitidine Tablets USP,
150 mg
ACID REDUCER
PREVENTS & RELIEVES
HEARTBURN
associated with
acid indigestion and sour stomach
 8 TABLETS
(8 DOSES)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Blister Carton (8's (1 x 8) Tablets)
MAXIMUM STRENGTH RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-734
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)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code K;43
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-734-021 in 1 CARTON04/24/201907/08/2021
18 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-734-071 in 1 CARTON11/13/201707/08/2021
224 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-734-171 in 1 CARTON11/13/201707/08/2021
345 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-734-141 in 1 CARTON11/13/201707/08/2021
450 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-734-161 in 1 CARTON11/13/201707/08/2021
565 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-734-501 in 1 CARTON11/13/201707/08/2021
685 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:58602-734-201 in 1 CARTON11/13/201707/08/2021
795 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:58602-734-401 in 1 CARTON11/13/201707/08/2021
8500 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:58602-734-791 in 1 CARTON11/12/201907/08/2021
98 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(58602-734) , MANUFACTURE(58602-734)

Revised: 7/2021
 
Aurohealth LLC