Zantac 75 (Ranitidine) Tablet [Jc World Bell Wholesale Co., Inc.] -

ZANTAC 75 (RANITIDINE) TABLET [JC WORLD BELL WHOLESALE CO., INC.]
PDF | XML

NDC	50269-222-25
Set ID	1f79c236-966d-4398-aa4b-88d67967f78b
Category	HUMAN OTC DRUG LABEL
Packager	JC World Bell Wholesale Co., Inc.
Generic Name
Product Class
Product Number
Application Number	NDA020520

View All Sections

Drug Facts
Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 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
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.
Inactive ingredients

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 75
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50269-222
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	75 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;75
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50269-222-25	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	NDA020520	07/29/2016

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

View All Sections

Medic

ZANTAC 75 (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.

Related Drugs