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basic care childrens allergy relief

Amazon Children’s Allergy Relief Drug Facts

Approved
Approval ID

90f40330-46a6-44cf-9b09-6f791c9b210b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

Amazon.com Services LLC

DUNS: 128990418

Products 1

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

Loratadine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72288-511
Application NumberANDA075728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (11)

LORATADINEActive
Quantity: 5 mg in 5 mL
Code: 7AJO3BO7QN
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/5/2025

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

LOINC: 34067-9Updated: 6/2/2021

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/2/2021

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/2/2021

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 6/2/2021

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).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/2/2021

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 6/2/2021

Inactive ingredients

edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

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basic care childrens allergy relief - FDA Drug Approval Details