Ranitidine by Shopko Stores Operating Co., LLC. RANITIDINE tablet

Ranitidine by

Drug Labeling and Warnings

Ranitidine by is a Otc medication manufactured, distributed, or labeled by Shopko Stores Operating Co., LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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:

• frequent chest pain     
• unexplained weight loss 
• stomach pain
• 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 wheezing, particularly with heartburn 
• nausea or vomiting      

Stop use and ask a doctor if

• your heartburn continues or worsens
• stomach pain continues
• you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health care 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 older:
  • 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 of age: ask a doctor

Other information

• do not use if printed foil under cap is torn or open
• store at controlled room temperature 20°-25°C (68°-77°F)
• avoid excessive heat or humidity
• this product is sugar free
• *This product is not manufactured or distributed by Glaxosmithkline Consumer Healthcare, owner of the registered trademark Zantac® 150

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C yellow # 6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.

Principal display panel

SHOPKO®

Maximum Strength HEARTBURN

Ranitidine Tablets, USP 150 mg

Acid Reducer

One tablet relieves: heartburn, acid indigestion & sour stomach

*Compare to Zantac 150® active ingredient

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

Packaged by:

PL Developments

200 Hicks street

Westbury, NY 11590, USA

Questions or comments?

call toll free 1-877-753-3935

Product of INDIA

Product Label

Ranitidine 150 mg

INGREDIENTS AND APPEARANCE

RANITIDINE 
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-127
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIETHYL PHTHALATE (UNII: UF064M00AF)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	HEXAGON (6 SIDED)	Size	10mm
Flavor		Imprint Code	W;741
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-127-50	1 in 1 CARTON
1		50 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078653	07/11/2010

Labeler - Shopko Stores Operating Co., LLC. (023252638)