MAXIMUM STRENGTH ZANTAC- ranitidine tablet, coated

Maximum Strength Zantac by

Drug Labeling and Warnings

Maximum Strength Zantac 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 150 mg (as ranitidine hydrochloride 168 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
• if you have kidney disease, except under the advice and supervision of a doctor

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)
• 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 20º-25ºC (68º-77ºF)
• avoid excessive heat or humidity
• this product is sodium and sugar free

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red 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.

Boehringer Ingelheim Consumer Health Care Products
Division of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
Copyright © 2015, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.
Product of Spain. Manufactured in Mexico.

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

Zantac 150 mg - 24 Count Blister Carton

PRINCIPAL DISPLAY PANEL

Zantac 150 mg - 65 Count Bottle Carton

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH ZANTAC 
ranitidine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0121
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	150 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 (Dark Pink)	Score	no score
Shape	PENTAGON (5 sided)	Size	4mm
Flavor		Imprint Code	Z;150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0121-06	1 in 1 CARTON	12/21/2006	11/30/2021
1		3 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0597-0121-50	1 in 1 CARTON	12/21/2006	11/30/2021
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0597-0121-08	1 in 1 POUCH; Type 0: Not a Combination Product	12/21/2006	11/30/2021
4	NDC: 0597-0121-09	4 in 1 CARTON	12/21/2006	11/30/2021
4		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 0597-0121-24	3 in 1 CARTON	12/21/2006	11/30/2021
5		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 0597-0121-38	1 in 1 CARTON	12/21/2006	11/30/2021
6		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 0597-0121-64	1 in 1 CARTON	12/21/2006	11/30/2021
7		65 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 0597-0121-68	1 in 1 CARTON	12/21/2006	11/30/2021
8		65 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 0597-0121-80	80 in 1 CARTON	12/21/2006	11/30/2021
9		1 in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 0597-0121-82	80 in 1 CARTON	12/21/2006	11/30/2021
10		1 in 1 POUCH; Type 0: Not a Combination Product
11	NDC: 0597-0121-94	1 in 1 CARTON	12/21/2006	11/30/2021
11		45 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 0597-0121-90	2 in 1 CARTON	12/21/2006	11/30/2021
12		45 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 0597-0121-85	1 in 1 CARTON	12/21/2006	11/30/2021
13		85 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 0597-0121-01	2 in 1 CARTON	12/21/2006	11/30/2021
14		50 in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 0597-0121-78	1 in 1 CARTON	12/21/2006	11/30/2021
15		78 in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 0597-0121-66	1 in 1 CARTON	12/21/2006	11/30/2021
16		40 in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 0597-0121-11	2 in 1 CARTON	12/21/2006	11/30/2021
17		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021698	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(0597-0121)

Establishment
Name	Address	ID/FEI	Business Operations
Boehringer Ingelheim Promeco S.A de C.V.		812579472	label(0597-0121) , analysis(0597-0121) , manufacture(0597-0121) , pack(0597-0121)