Zantac 75

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
• 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

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) • do not chew tablet
• children under 12 years: ask a doctor

Other information

• do not use if individual foil packet is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity • this product is sodium and sugar free

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, 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:

Outer Package Inner Package Zantac

ZANTAC 75
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0597-0222
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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	Marketing End Date
Packaging
1	NDC:0597-0222-25	25 in 1 BOX	04/15/2016	06/28/2016
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	04/15/2016	06/28/2016

Labeler - Boehringer Ingelheim Promeco S.A. de C.V. (603175944)

Name	Address	ID/FEI	Business Operations
Establishment
JC World Bell Wholesale Co., Inc.		805257581	repack(0597-0222)

Revised: 6/2016

Document Id: 365866b1-f6a3-5fb3-e054-00144ff88e88

Set id: 9a386d1e-f441-4ba1-bb32-c3ea828c41bd

Version: 3

Effective Time: 20160628

Boehringer Ingelheim Promeco S.A. de C.V.