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 Atlantic Biologicals. 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?

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch/report.htm

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS

MIAMI,FL 33179

Package/Label Principal Display Panel

Compare to the active ingredient in Children’s Claritin ®

children’s loratadine oral solution

loratadine oral solution USP, 5 mg/5 mL

antihistamine

allergy

indoor & outdoor allergies

non-drowsy *

24-hour relief of:

sneezing

runny nose

itchy, watery eyes

itchy throat or nose

dye-free

sugar-free

ages 2 years and older

*when taken as directed. See drug facts panel.

grape flavor

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE ORAL 
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-6767(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)
WATER (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: 17856-6767-1	72 in 1 CASE	02/05/2026
1		5 mL in 1 CUP, UNIT-DOSE; 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 - Atlantic Biologicals (047437707)