ZANTAC 75- ranitidine tablet, coated

Zantac 75 by

Drug Labeling and Warnings

Zantac 75 by is a Otc medication manufactured, distributed, or labeled by Boehringer Ingelheim Pharmaceuticals Inc., Patheon Manufacturing Services LLC, Boehringer Ingelheim Promeco S.A de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active ingredient (in each tablet): Purpose
• Ranitidine 75 mg (as ranitidine hydrochloride 84 mg) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .: 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

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 printed foil under bottle cap is open or torn (bottles)
• do not use if individual blister unit is open or torn (blisters)
• do not use if individual foil packet is open or torn (pouch)
• 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

SPL UNCLASSIFIED SECTION

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products
Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877
© 2016, BI Pharmaceuticals, Inc. All rights reserved.
Product of Spain. Manufactured in Mexico.

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

Zantac 75mg - 30ct Blister Packs
NDC: 0597-0122-27

PRINCIPAL DISPLAY PANEL

Zantac 75mg - 80 ct Carton
NDC: 0597-0122-81

INGREDIENTS AND APPEARANCE

ZANTAC 75 
ranitidine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0122
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	pink	Score	no score
Shape	PENTAGON (5 sided)	Size	3mm
Flavor		Imprint Code	Z;75
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0122-34	1 in 1 CARTON	12/21/2006	11/30/2021
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0597-0122-54	1 in 1 CARTON	12/21/2006	11/30/2021
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0597-0122-81	1 in 1 CARTON	12/21/2006	11/30/2021
3		80 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0597-0122-40	4 in 1 CARTON	12/21/2006	11/30/2021
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 0597-0122-61	100 in 1 CARTON	12/21/2006	11/30/2021
5		1 in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 0597-0122-96	1 in 1 CARTON	12/21/2006	11/30/2021
6		96 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0597-0122-08	1 in 1 POUCH; Type 0: Not a Combination Product	12/21/2006	11/30/2021
8	NDC: 0597-0122-01	2 in 1 CARTON	12/21/2006	11/30/2021
8		1 in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 0597-0122-37	3 in 1 CARTON	12/21/2006	11/30/2021
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC: 0597-0122-13	1 in 1 CARTON	12/21/2006	11/30/2021
10		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020520	12/21/2006	11/30/2021

Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Manufacturing Services LLC		079415560	manufacture(0597-0122)

Establishment
Name	Address	ID/FEI	Business Operations
Boehringer Ingelheim Promeco S.A de C.V.		812579472	pack(0597-0122) , analysis(0597-0122) , label(0597-0122) , manufacture(0597-0122)