MAXIMUM STRENGTH RANITIDINE- ranitidine tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Available from:
Aurohealth LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer - 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 - 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 - 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 taking a prescription drug. Acid reducers may interact with certain prescription drugs. - your heartburn continues or worsens - you need to take this product for more than 14 days
Authorization status:
Abbreviated New Drug Application
Authorization number:
58602-740-07, 58602-740-14, 58602-740-16, 58602-740-19, 58602-740-20, 58602-740-40, 58602-740-72, 58602-740-79

MAXIMUM STRENGTH RANITIDINE - ranitidine tablet

Aurohealth LLC

----------

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 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 Blister Carton (24's (3 x 8)

T ablets )

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)

MAXIMUM STRENGTH RANITIDINE

ranitidine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 6 0 2-740

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

RANITIDINE HYDRO CHLO RIDE (UNII: BK76 46 5IHM) (RANITIDINE - UNII:8 8 4KT10 YB7)

RANITIDINE

150 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

HYPRO MELLO SE 2 9 10 ( 5 MPA.S) (UNII: R75537T0 T4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

MINT (UNII: FV9 8 Z8 GITP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

MINT

Imprint Code

K;49

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 6 0 2-740 -16

1 in 1 CARTON

11/13/20 17

1

6 5 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:58 6 0 2-740 -20

1 in 1 CARTON

11/13/20 17

2

9 5 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:58 6 0 2-740 -72

3 in 1 CARTON

11/13/20 17

3

NDC:58 6 0 2-740 -79

8 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:58 6 0 2-740 -0 7 1 in 1 CARTON

11/12/20 19

4

24 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

5

NDC:58 6 0 2-740 -14

1 in 1 CARTON

11/12/20 19

5

50 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:58 6 0 2-740 -19

1 in 1 CARTON

11/12/20 19

6

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

7

NDC:58 6 0 2-740 -40

1 in 1 CARTON

11/12/20 19

7

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Aurohealth LLC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 7578

11/13/20 17

Labeler -

Aurohealth LLC (078728447)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Auro bindo Pharma Limited

6 50 38 19 0 3

ANALYSIS(58 6 0 2-740 ) , MANUFACTURE(58 6 0 2-740 )

Revised: 11/2019

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