Zantac 150 (Ranitidine) Tablet [Jc World Bell Wholesale Co., Inc.] -

ZANTAC 150 (RANITIDINE) TABLET [JC WORLD BELL WHOLESALE CO., INC.]
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NDC	50269-220-25
Set ID	7c6212f5-91fb-438c-80fb-b694c48207b7
Category	HUMAN OTC DRUG LABEL
Packager	JC World Bell Wholesale Co., Inc.
Generic Name
Product Class
Product Number
Application Number	NDA021698

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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:

INGREDIENTS AND APPEARANCE

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
Packaging
1	NDC:50269-220-25	25 in 1 BOX	07/29/2016
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

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

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Medic

ZANTAC 150 (RANITIDINE) TABLET [JC WORLD BELL WHOLESALE CO., INC.]

Purpose

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

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