ZANTAC 150- ranitidine tablet
JC World Bell Wholesale Co., Inc.

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Zantac 150

Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Purpose

Acid reducer

Uses

relieves heartburn associated with acid indigestion and sour stomach
relieves 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
if you have kidney disease, except under the advice and supervision of a doctor.

Ask a doctor before use if you have

had hertburn 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

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 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

do not use if individual foil pouch is open or torn
avoid excessive heat or humidity
store at 20 0-25 0C (68 0-77 0F)
this product is sodium and sugar free

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide,titanium dioxide, triacetin.

Questions?

call 1-888-285-9159 (English/Spanish)M-F, 8:30-5 EST, or visit www.zantacotc.com for Tips for Managing Heartburn

Package Labeling:

Label

ZANTAC 150
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50269-220
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	orange	Score	no score
Shape	PENTAGON (5 sided)	Size	7mm
Flavor		Imprint Code	Z;150
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50269-220-25	25 in 1 BOX	07/29/2016	11/01/2021
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021698	07/29/2016	11/01/2021

Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Revised: 10/2021

Document Id: ceb93b83-d823-0494-e053-2995a90a86c4

Set id: 7c6212f5-91fb-438c-80fb-b694c48207b7

Version: 6

Effective Time: 20211019

JC World Bell Wholesale Co., Inc.

Zantac 150

​Drug Facts

​Active ingredient (in each tablet)

​Purpose

​Uses

​Warnings