RANITIDINE 150- ranitidine hydrochloride tablets 150mg tablet, coated

Ranitidine 150 by

Drug Labeling and Warnings

Ranitidine 150 by is a Otc medication manufactured, distributed, or labeled by Allegiant Health, Apotex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Ranitidine 150mg (as ranitidine hydrochloride, USP 168mg)

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

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 (1-800-222-1222) right away.

Directions

adults and children 12 years of age 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 the individual blister unit is open or torn
• store at 20ºC to 25ºC (68ºF to 77ºF)
• avoid excessive heat or humidity
• protect from light
• this product is sodium and sugar free

Inactive ingredients

carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, red and yellow 

ferric oxide, silicon dioxide, titanium dioxide, vanillin

Questions or comments?

1-888-952-0050 Monday through Friday 9AM-5PM EST

Principal Display Panel

Acid Reducer 150mg

INGREDIENTS AND APPEARANCE

RANITIDINE 150 
ranitidine hydrochloride tablets 150mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-375
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
VANILLIN (UNII: CHI530446X)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	APO;150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-375-29	1 in 1 CARTON	01/05/2010
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69168-375-93	2 in 1 CARTON	01/05/2010
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078192	01/05/2010

Labeler - Allegiant Health (079501930)

Establishment
Name	Address	ID/FEI	Business Operations
Apotex Inc.		205576023	ANALYSIS(69168-375) , MANUFACTURE(69168-375)