CHILDRENS LORATADINE ORAL- loratadine solution 
Major Pharmaceuticals

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Major Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

Uses

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

use only with enclosed dosing cup

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

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)

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?

1-800-616-2471

Package/Label Principal Display Panel

Compare to the active ingredient in Children’s Claritin®

Children’s Loratadine Oral Solution, USP, 5 mg/5 mL

(Antihistamine)

ALLERGY

Non-Drowsy†

Indoor & Outdoor Allergies

SUGAR FREE

Dye Free

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Ages 2 years and older

Dosing Cup Enclosed

Grape Flavor

†When taken as directed.

See Drug Facts Panel.

4 FL OZ (120 mL)

6t5-5c-childrens-loratadine-oral-solution
CHILDRENS LORATADINE ORAL 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6767
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6767-201 in 1 CARTON02/12/2019
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07572802/12/2019
Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2020
Document Id: c1d82e33-5de9-40b0-8e03-be47e98c466c
Set id: 3f0f0131-b516-4ff3-8049-3d3766324b66
Version: 2
Effective Time: 20200825
 
Major Pharmaceuticals