CHILDRENS LORATADINE- 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:
TARGET CORPORATION
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Authorization status:
Abbreviated New Drug Application
Authorization number:
11673-997-30

CHILDRENS LORATADINE- loratadine tablet, chewable

TARGET CORPORATION

----------

CHILDREN'S LORATADINE

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:

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 or kidney

disease

ask a doctor

runny nose

itchy, watery eyes

sneezing

itching of the nose or throat

Other information

Inactive ingredients

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

mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Ques tions ?

Call 1-800-910-6874

Distributed by Target Corporation

Minneapolis, MN 55403

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

NDC 11673-997-30

Compare to active ingredient in Children's Claritin Chewables*

children's

allergy

loratadine chewable tablets USP, 5 mg

antihistamine

up&up

non-drowsy**

indoor and outdoor allergies

24-hour relief of:

sneezing

runny nose

itchy, watery eyes

itchy throat or nose

**When taken as directed. See drug facts panel.

30 CHEWABLE TABLETS

THE CHEWABLE TABLETS ARE

TO BE CHEWED BEFORE SWALLOWING

BUBBLEGUM

FLAVOR

ACTUAL SIZE

CHEWABLE

TABLETS

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).

CHILDRENS LORATADINE

loratadine tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:116 73-9 9 7

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 chinea l (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:116 73-9 9 7-30

3 in 1 CARTON

0 3/31/20 19

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 3/31/20 19

Labeler -

T ARGET CORPORAT ION (006961700)

TARGET CORPORATION

Registrant -

Ohm Laboratories (051565745)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ohm Labo rato ries

18 476 9 0 29

MANUFACTURE(116 73-9 9 7)

Revised: 8/2019

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