RANITIDINE 150- ranitidine hcl tablets 150mg tablet, coated
Marc Glassman, Inc.

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375 - Acid Reducer 150

Active ingredients (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride, USP 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 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,

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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 the individual blister unit is open or torn
store at 20°C to 25°C (68°F to 77°F)
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

Principal Display Panel

NDC 68998-375-93

*Compare to the Active Ingredient in Zantac150®

Marc's (logo)

maximum strength

Acid Reducer 150

RANITIDINE 150 mg

Relieves & Prevents Heartburn

(pill image)

24 Tablets

Ranitidine 150mg

RANITIDINE 150
ranitidine hcl tablets 150mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68998-375
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
VANILLIN (UNII: CHI530446X)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68998-375-93	2 in 1 CARTON	01/05/2010	09/30/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078192	01/05/2010	09/30/2020

Labeler - Marc Glassman, Inc. (094487477)

Revised: 11/2017

Document Id: ecdc684c-f442-4ba6-b584-be6bd826ca12

Set id: 75970c03-1537-441d-a626-ceb2e1fe2abc

Version: 4

Effective Time: 20171115

Marc Glassman, Inc.