CHILDRENS LORATADINE ORAL- loratadine solution

Childrens Loratadine Oral by

Drug Labeling and Warnings

Childrens Loratadine Oral by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

1-800-719-9260

HOW SUPPLIED

Product: 50090-7516

NDC: 50090-7516-0 120 mL in a BOTTLE / 1 in a CARTON

Loratadine

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE ORAL 
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-7516(NDC:0904-6767)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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)
AQUA (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-7516-0	1 in 1 CARTON	03/10/2025
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075728	02/12/2019

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-7516)