ZANTAC 75- ranitidine tablet

Zantac 75 by

Drug Labeling and Warnings

Zantac 75 by is a Otc medication manufactured, distributed, or labeled by JC World Bell Wholesale Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50269-222-25	25 in 1 BOX	07/29/2016
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020520	07/29/2016

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