ZANTAC 150

Main information

  • Trade name:
  • ZANTAC 150- ranitidine tablet
  • Composition:
  • RANITIDINE 150 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZANTAC 150- ranitidine tablet
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • • 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

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • New Drug Application
  • Authorization number:
  • 67751-151-01
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

ZANTAC 150- ranitidine tablet

Navajo Manufacturing Company Inc.

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Zantac 150

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, necks 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 health 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

Ques tions ?

call 1-888-285-9159 (English/Spanish) M – F, 8:30 – 5 EST, or visit www.zantacotc.com for Tips for

Managing Heartburn

Package Labeling:

ZANTAC 150

ranitidine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7751-151(NDC:0 59 7-0 121)

Navajo Manufacturing Company Inc.

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

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

pink

S core

no sco re

S hap e

PENTAGON (5 sided)

S iz e

Flavor

Imprint Code

Z;150

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7751-151-0 1

1 in 1 CARTON

0 9 /16 /20 16

1

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 216 9 8

0 9 /16 /20 16

Labeler -

Navajo Manufacturing Company Inc. (091917799)

Revised: 9/2016