EQUALINE CHILDRENS ALLERGY RELIEF- loratadine solution

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

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
Supervalu Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: if you have ever had an allergic reaction to this product or any of its ingredients liver or kidney disease. Your doctor should determine if you need a different dose. an allergic reaction to this product occurs. Seek medical help right away.
Authorization status:
Abbreviated New Drug Application
Authorization number:
41163-633-26

EQUALINE CHILDRENS ALLERGY RELIEF- loratadine solution

Supervalu Inc

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SuperValu Inc. Children’s Allergy Relief Drug Facts

Active ingredient (in each 5 mL teaspoonful)

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

runny nose

itchy, watery eyes

sneezing

itching of the nose or throat

adults and children 6 years and over

2 teaspoonfuls (tsp) daily; do not take more than 2

teaspoonfuls (tsp) in 24 hours

children 2 to under 6 years of age

1 teaspoonful (tsp) daily; do not take more than 1

teaspoonful (tsp) 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

edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor,

phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

1-877-932-7948

Principal Display Panel

compare to Children’s Claritin® active ingredient

children’s

allergy

relief

loratadine oral solution 5 mg/5 mL (antihistamine)

indoor & outdoor allergies

non-drowsy*

24 hour relief of:

sneezing

runny nose

itchy, watery eyes

itchy throat or nose

DYE-FREE

ages 2 years and older

grape flavor

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

4 FL OZ (120 mL)

use only with enclosed dosing cup

do not use if carton is opened, or if printed neckband is broken or missing

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

EQUALINE CHILDRENS ALLERGY RELIEF

loratadine solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4116 3-6 33

Route of Administration

ORAL

Active Ingredient/Active Moiety

Supervalu Inc

Ingredient Name

Basis of Strength

Stre ng th

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

LORATADINE

5 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

MALTITO L (UNII: D6 5DG142WK)

SO DIUM PHO SPHATE, MO NO BASIC (UNII: 39 8 0 JIH2SW)

PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4116 3-6 33-26

1 in 1 CARTON

0 1/0 9 /20 19

1

120 mL 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 75728

0 1/0 9 /20 19

Labeler -

Supervalu Inc (006961411)

Registrant -

L. Perrigo Company (006013346)

Revised: 3/2019

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