RANITIDINE - ranitidine tablet, film coated 
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 75 mg (as ranitidine hydrochloride USP 83.707 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, 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.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (60 Tablets Bottle)

AUROHEALTH

NDC 58602-733-15

Regular Strength

Ranitidine
Tablets USP,
75 mg

ACID
REDUCER

PREVENTS & RELIEVES
HEARTBURN
associated with acid
indigestion and sour stomach

60 TABLETS (60 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (60 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (60 Tablets Container Carton )


AUROHEALTH
NDC 58602-733-15
*Compare to the active
ingredient in Zantac 75®

Regular Strength

Ranitidine
Tablets USP,
75 mg

ACID
REDUCER

PREVENTS & RELIEVES
HEARTBURN
associated with acid
indigestion and sour stomach

60 TABLETS (60 DOSES
)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (60 Tablets Container Carton )

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg Blister Carton (10 Tablets)

AUROHEALTH

NDC 58602-733-03

*Compare to the active
ingredient in Zantac 75®

Regular Strength

Ranitidine
Tablets USP,
75 mg

ACID
REDUCER

PREVENTS & RELIEVES
HEARTBURN
associated with acid
indigestion and sour stomach

10 TABLETS (10 DOSES
)



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg Blister Carton (10's Tablets)


RANITIDINE 
ranitidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-733
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 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
ShapeROUNDSize6mm
FlavorImprint Code K;42
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-733-091 in 1 CARTON11/13/201707/08/2021
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-733-151 in 1 CARTON11/13/201707/08/2021
260 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-733-181 in 1 CARTON11/13/201707/08/2021
380 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-733-221 in 1 CARTON11/13/201707/08/2021
4105 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-733-231 in 1 CARTON11/13/201707/08/2021
5120 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-733-301 in 1 CARTON11/13/201707/08/2021
6160 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:58602-733-401 in 1 CARTON11/13/201707/08/2021
7500 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:58602-733-031 in 1 CARTON11/13/201707/08/2021
810 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20757911/13/201707/08/2021
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-733) , MANUFACTURE(58602-733)

Revised: 7/2021
 
Aurohealth LLC