WAL-ITIN- loratadine tablet, chewable

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

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
Walgreens
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose - itchy, watery eyes - sneezing - itching of the nose or throat
Authorization status:
Abbreviated New Drug Application
Authorization number:
0363-0754-30

WAL-ITIN- loratadine tablet, chewable

Walgreens

----------

Wal-itin

Drug Facts

Active ingredient (in each tablet)

Loratadine USP, 5 mg

Purpos e

Antihistamine

Us es

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

itchy, watery eyes

sneezing

itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you

need a different dose.

When using this product do not take more than directed. Taking more than directed may cause

drowsiness.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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 (1-800-222-1222).

Directions

chew or crush tablets completely before swallowing.

adults and

children

6 years and

over

chew 2 tablets daily; not

more

than 2 tablets in 24

hours

children 2 to

under

6 years of age

chew 1 tablet daily; not

more

than 1 tablet in 24 hours

children under

2 years of age

ask a doctor

consumers with

liver

®

liver

or kidney

disease

ask a doctor

Other information

phenylketonurics: contains phenylalanine 1.25 mg per tablet.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR

SHOW ANY SIGNS OF TAMPERING.

store between 20° to 25°C (68° to 77°F).

Inactive ingredients

aspartame, carmine, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate,

mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Ques tions ?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

children's

ALLERGY

Wal-itin

LORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE

Walgreens

Compare to Children's Claritin

Chewables active ingredient

NDC 0363-0754-30

CHEWABLE

NON-DROWSY*

24-HOUR RELIEF

24-hour relief of sneezing, runny nose,

itchy throat or nose, & itchy, watery eyes

Indoor & outdoor allergies

CHEWABLE

TABLETS

The chewable tablets are to be chewed before swallowing.

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

BUBBLEGUM

FLAVOR

ACTUAL SIZE

††

AGES

YEARS &

OLDER

WAL-ITIN

loratadine tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 754

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)

LORATADINE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

a spa rta me (UNII: Z0 H242BBR1)

CO CHINEAL (UNII: TZ8 Z31B35M)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

ma nnito l (UNII: 3OWL53L36 A)

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

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

stea ric a cid (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

PINK (light to medium pink with a slightly speckled appearance)

S core

no sco re

S hap e

ROUND (Flat face, beveled edge)

S iz e

10 mm

Flavor

BUBBLE GUM

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:0 36 3-0 754-30

3 in 1 CARTON

0 3/0 1/20 18

1

10 in 1 BLISTER PACK; 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

ANDA210 0 8 8

0 3/0 1/20 18

Labeler -

Walgreens (008965063)

Registrant -

Ohm Laboratories (184769029)

Walgre e ns

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ohm Labo rato ries

18 476 9 0 29

MANUFACTURE(0 36 3-0 754)

Revised: 7/2019

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