MAXIMUM STRENGTH RANITIDINE- ranitidine tablet

MAXIMUM STRENGTH RANITIDINE by

Drug Labeling and Warnings

MAXIMUM STRENGTH RANITIDINE by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Saraca Laboratories Limited, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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 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)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH RANITIDINE 
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-734
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	150 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	K;43
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-734-02	1 in 1 CARTON	04/24/2019
1		8 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-734-07	1 in 1 CARTON	11/13/2017
2		24 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-734-17	1 in 1 CARTON	11/13/2017
3		45 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58602-734-14	1 in 1 CARTON	11/13/2017
4		50 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-734-16	1 in 1 CARTON	11/13/2017
5		65 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 58602-734-50	1 in 1 CARTON	11/13/2017
6		85 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 58602-734-20	1 in 1 CARTON	11/13/2017
7		95 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 58602-734-40	1 in 1 CARTON	11/13/2017
8		500 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 58602-734-79	1 in 1 CARTON	11/12/2019
9		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207578	11/13/2017

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-734) , MANUFACTURE(58602-734)