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Childrens Loratadine Oral

Loratadine · Solution

Over-the-counter ANDA Official labelling

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Childrens Loratadine Oral

Generic name

Loratadine

Dosage form

Solution

Route

Oral

Marketing category

ANDA · ANDA

Labeler

A-S Medication Solutions

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Loratadine	5 mg/5mL	311372	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

Route of administration

Oral

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

075728

Application type

ANDA · Abbreviated New Drug Application

Approval date

August 20, 2004

Sponsor

PERRIGO

Products on application

Submissions recorded

Products approved under application 075728.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
075728-001	LORATADINE	SYRUP		LORATADINE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 075728.
Type	No.	Action	Status	Date	Review
Supplement	15	Manufacturing (CMC)	Approved	June 1, 2018	Unknown
Original application	1		Approved	August 20, 2004	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260318). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260318 HUMAN OTC DRUG · 20251113

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

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

Warnings

openFDA Drug Labeling

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).

Do Not Use

openFDA Drug Labeling

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

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

Adverse event reports

Source: openFDA FAERS

114,194

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LORATADINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
50090-7516-0	50090-7516	A-S Medication Solutions	1 BOTTLE in 1 CARTON (50090-7516-0) / 120 mL in 1 BOTTLE	March 10, 2025
17856-6767-1	17856-6767	Atlantic Biologicals	72 CUP, UNIT-DOSE in 1 CASE (17856-6767-1) / 5 mL in 1 CUP, UNIT-DOSE	February 5, 2026
0904-6767-20	0904-6767	Major Pharmaceuticals	1 BOTTLE in 1 CARTON (0904-6767-20) / 120 mL in 1 BOTTLE	February 12, 2019
50090-7516	50090-7516	A-S Medication Solutions	—	February 12, 2019
17856-6767	17856-6767	Atlantic Biologicals	—	February 12, 2019
0904-6767	0904-6767	Major Pharmaceuticals	—	February 12, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.