RANITIDINE 150- ranitidine hcl tablets 150mg tablet, coated

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Available from:
Marc Glassman, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer - 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
68998-397-93

RANITIDINE 150- ranitidine hcl tablets 150mg tablet, coated

Marc Glassman, Inc.

----------

Acid Reducer 150

Active ingredients (in each tablet)

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

Purpos e

Acid reducer

Us es

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

croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene

glycol, polyvinyl alcohol, talcum, titanium dioxide

Principal Display Panel

NDC 68998-397-93

*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

Acid Reducer 150

RANITIDINE 150

ranitidine hcl tablets 150mg tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 9 9 8 -39 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

RANITIDINE HYDRO CHLO RIDE (UNII: BK76 46 5IHM) (RANITIDINE - UNII:8 8 4KT10 YB7)

RANITIDINE

150 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L 10 0 0 (UNII: U0 76 Q6 Q6 21)

PO LYVINYL ALCO HO L ( 10 0 0 0 0 MW) (UNII: 9 49 E52Z6 MY)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

BROWN

S core

no sco re

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

G;150

Contains

Marc Glassman, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 8 9 9 8 -39 7-

2 in 1 CARTON

10 /0 1/20 18

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 19 2

10 /0 1/20 18

Labeler -

Marc Glassman, Inc. (094487477)

Revised: 9/2019

Similar products

Search alerts related to this product

View documents history

Share this information