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FDA Approval

basic care childrens allergy relief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 12, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Loratadine(5 mg in 5 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

basic care childrens allergy relief

Product Details

NDC Product Code
72288-511
Application Number
ANDA075728
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 12, 2025
Code: 7AJO3BO7QNClass: ACTIBQuantity: 5 mg in 5 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
MALTITOLInactive
Code: D65DG142WKClass: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SWClass: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NNClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package/Label Principal Display Panel

amazon

basic care

Ages 2 Years and Older

Compare to Children’s Claritin® active ingredient

Children’s Allergy Relief

Loratadine Oral Solution, 5 mg/5 mL

Antihistamine

Non-Drowsy*

Indoor & Outdoor Allergies

24 Hour Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Grape Flavor

Dye-Free

*When taken as directed. See Drug Facts Panel.

8 FL OZ (240 mL)

![amazon-childrens-allergy-relief-grape-carton- image.jpg](/dailymed/image.cfm?name=amazon-childrens-allergy-relief-grape- carton-image.jpg&id=874824)


INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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)

WARNINGS SECTION

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).


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine


INACTIVE INGREDIENT SECTION

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


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