Zantac 150

Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 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
• 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, necks 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
• store at 20°-25°C (68°-77°F)
• 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 for Tips for Managing Heartburn

Package Labeling:

Zantac 150

ZANTAC 150
ranitidine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67751-151(NDC:0597-0121)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	150 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	pink	Score	no score
Shape	PENTAGON (5 sided)	Size	4mm
Flavor		Imprint Code	Z;150
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67751-151-01	1 in 1 CARTON	09/16/2016	10/18/2019
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021698	09/16/2016	10/18/2019

Labeler - Navajo Manufacturing Company Inc. (091917799)

Name	Address	ID/FEI	Business Operations
Establishment
Navajo Manufacturing Company Inc.		136941411	relabel(67751-151) , repack(67751-151)

Revised: 7/2022

Document Id: e4e3fd9b-1035-2015-e053-2995a90a45b7

Set id: 4e7e07a5-4fc6-4d31-9f75-3920e823da17

Version: 3

Effective Time: 20220728

Navajo Manufacturing Company Inc.