ZANTAC 150 ACID REDUCER- ranitidine tablet

Zantac 150 by

Drug Labeling and Warnings

Zantac 150 by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, 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 healthcare 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 1-800-633-1610 or visit www.zantacotc.com

SPL UNCLASSIFIED SECTION

Product repackaged and distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW, Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 150 mg Tablet Pouch Carton

MAXIMUM STRENGTH
Zantac
Ranitidine Tablets 150 mg/Acid Reducer
150®

PREVENTS & RELIEVES
HEARTBURN associated with
acid indigestion and sour stomach

3 Tablets
(3 Doses)

Lil'
Drug Store®

INGREDIENTS AND APPEARANCE

ZANTAC 150   ACID REDUCER
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9736
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
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Ferric Oxide Red (UNII: 1K09F3G675)
Titanium Dioxide (UNII: 15FIX9V2JP)
Triacetin (UNII: XHX3C3X673)

Product Characteristics
Color	BROWN	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: 66715-9736-2	2 in 1 CARTON	11/01/2010
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9736-3	3 in 1 CARTON	11/01/2010
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 66715-9736-8	5 in 1 CARTON	11/01/2010
3		1 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 66715-9736-6	20 in 1 CARTON	11/01/2010	12/31/2017
4		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021698	11/01/2010

Labeler - Lil' Drug Store Products, Inc (093103646)