WAL-ZAN

Main information

  • Trade name:
  • WAL-ZAN- ranitidine hydrochloride tablets 150mg tablet, coated
  • Composition:
  • RANITIDINE 150 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • WAL-ZAN- ranitidine hydrochloride tablets 150mg tablet, coated
    United States
  • Language:
  • English

Therapeutic information

  • 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 eating or drinking certain foods and beverages

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 0363-0010-01, 0363-0010-23, 0363-0010-26, 0363-0010-32, 0363-0010-34, 0363-0010-50, 0363-0010-61, 0363-0010-62
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

WAL-ZAN- ranitidine hydrochloride tablets 150mg tablet, coated

Walgreens Company

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Drug Facts

Active ingredient (in each tablet)

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

Purpos e

Acid reducer

Us e(s )

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, neck or

shoulders; or lightheadedness

frequent chest pain

frequent wheezing, particularly with heartburn

unexplained weight loss

nausea or vomiting

stomach pain

Stop use and ask 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 printed foil under bottle cap is open or torn

store at 20°-25°C (68°-77°F)

avoid excessive heat or humidity

protect from light

this product is sodium and sugar free

Inactive ingredients

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, titanium dioxide

Ques tions

call 1-888-375-3784

TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP PRINTED WITH "SEALED

FOR YOUR PROTECTION" IS BROKEN OR MISSING

IMPORTANT: Read the directions, consumer information leaflet and warnings before use. Keep

the carton. It contains important information.

container label

WAL-ZAN

ranitidine hydrochloride tablets 150mg tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 0 10 (NDC:55111-40 4)

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

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )

cellulo se, micro crysta lline (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

tita nium dio xide (UNII: 15FIX9 V2JP)

Product Characteristics

Color

PINK

S core

no sco re

Walgreens Company

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

R150

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-0 0 10 -34

1 in 1 CARTON

0 6 /11/20 11

1

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

2

NDC:0 36 3-0 0 10 -50

1 in 1 CARTON

0 6 /11/20 11

2

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

3

NDC:0 36 3-0 0 10 -6 2

1 in 1 CARTON

0 6 /11/20 11

3

9 5 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:0 36 3-0 0 10 -32

1 in 1 CARTON

0 6 /11/20 11

4

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

5

NDC:0 36 3-0 0 10 -0 1

1 in 1 CARTON

0 6 /11/20 11

5

20 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:0 36 3-0 0 10 -23

1 in 1 CARTON

0 6 /11/20 11

6

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

7

NDC:0 36 3-0 0 10 -26

1 in 1 CARTON

0 6 /11/20 11

7

6 5 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

8

NDC:0 36 3-0 0 10 -6 1

1 in 1 CARTON

0 6 /11/20 11

8

6 5 in 1 BOTTLE; 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

ANDA

ANDA0 78 19 2

0 6 /11/20 11

Labeler -

Walgreens Company (008965063)

Revised: 11/2017