DG HEALTH CHILDRENS ALLERGY RELIEF- 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:
Dolgencorp, LLC
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:
55910-807-52

DG HEALTH CHILDRENS ALLERGY RELIEF- loratadine tablet, chewable

Dolgencorp, LLC

----------

Dolgencorp, LLC Children’s Allergy Relief Drug Facts

Active ingredient (in each tablet)

Loratadine 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

adults and children 6 years and over

chew 2 tablets daily; not more than 2 tablets in 24

hours

runny nose

itchy, watery eyes

sneezing

itching of the nose or throat

chew or crush tablets completely before swallowing

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

Other information

Inactive ingredients

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue

#2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate,

stearic acid

Questions or comments?

1-888-309-9030

Principal Display Panel

Compare to the active ingredient of Children’s Claritin® Chewables

For Ages 2 + Years

Children’s Allergy Relief

Loratadine Chewable Tablets, 5 mg/Antihistamine

Non Drowsy*

24 Hour Relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose

Indoor & Outdoor Allergies

24 HOUR

Grape Flavor

10 Chewable Tablets

*When taken as directed. See Drug Facts Panel.

Actual Tablet Size

phenylketonurics: contains phenylalanine 1.4 mg per tablet

do not use if blister unit is broken or torn

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

DG HEALTH CHILDRENS ALLERGY RELIEF

loratadine tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:559 10 -8 0 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

ASPARTAME (UNII: Z0 H242BBR1)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

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

MANNITO L (UNII: 3OWL53L36 A)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

Dolgencorp, LLC

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

PURPLE (light)

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

GRAPE

Imprint Code

L3Y8

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:559 10 -8 0 7-52

10 in 1 CARTON

0 7/15/20 19

1

1 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 33

0 7/15/20 19

Labeler -

Dolgencorp, LLC (068331990)

Revised: 6/2020

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