ZANTAC 75- ranitidine tablet, coated
Boehringer Ingelheim Pharmaceuticals Inc.

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Zantac 75® Drug Facts

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. 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

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.

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

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

ZANTAC 75
ranitidine tablet, coated

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0597-0122-34	1 in 1 CARTON	12/21/2006	10/18/2019
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0597-0122-54	1 in 1 CARTON	12/21/2006	10/18/2019
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:0597-0122-81	1 in 1 CARTON	12/21/2006	10/18/2019
3		80 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:0597-0122-40	4 in 1 CARTON	12/21/2006	10/18/2019
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:0597-0122-61	100 in 1 CARTON	12/21/2006	10/18/2019
5		1 in 1 POUCH; Type 0: Not a Combination Product
6	NDC:0597-0122-96	1 in 1 CARTON	12/21/2006	10/18/2019
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	10/18/2019
8	NDC:0597-0122-01	2 in 1 CARTON	12/21/2006	10/18/2019
8		1 in 1 POUCH; Type 0: Not a Combination Product
9	NDC:0597-0122-37	3 in 1 CARTON	12/21/2006	10/18/2019
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:0597-0122-13	1 in 1 CARTON	12/21/2006	10/18/2019
10		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020520	12/21/2006	10/18/2019

Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Name	Address	ID/FEI	Business Operations
Establishment
Boehringer Ingelheim Promeco S.A de C.V.		812579472	PACK(0597-0122) , ANALYSIS(0597-0122) , LABEL(0597-0122) , MANUFACTURE(0597-0122)

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

Revised: 5/2021

Document Id: faa303f4-6295-46a4-b297-dda86fd08d71

Set id: 08556131-069b-4a1e-9190-98d3b62ada79

Version: 9

Effective Time: 20210501

Boehringer Ingelheim Pharmaceuticals Inc.