leader childrens allergy relief — Solution

Overview

Brand name

leader childrens allergy relief

Generic name

Loratadine

Dosage form

Solution

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Cardinal Health 110, LLC. dba Leader

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

2

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
Diphenhydramine Hydrochloride	12.5 mg/5mL	1049630	View
Loratadine	5 mg/5mL	311372	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

Route of administration

Oral

Presentations

4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Histamine H1 Receptor Antagonists [MoA]	MoA	All 136 members
Histamine-1 Receptor Antagonist [EPC]	EPC	All 134 members

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

1

Submissions recorded

2

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 20250722). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250722 HUMAN OTC DRUG · 20210617

Indications and Usage

openFDA Drug Labeling

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itching of the nose or throat • runny nose • itchy, watery eyes

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 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

openFDA Drug Labeling

Warnings Do not use • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if the child has • a breathing problem such as chronic bronchitis • glaucoma • a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • marked drowsiness may occur • excitability may occur, especially in children • sedatives and tranquilizers may increase drowsiness 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 • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if the child has • a breathing problem such as chronic bronchitis • glaucoma • a sodium-restricted diet

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

Adverse event reports

Source: openFDA FAERS

172,003

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: DIPHENHYDRAMINE HYDROCHLORIDE. 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
70000-0473-1	70000-0473	Cardinal Health 110, LLC. dba Leader	1 BOTTLE in 1 CARTON (70000-0473-1) / 120 mL in 1 BOTTLE	January 23, 2020
70000-0474-1	70000-0474	Cardinal Health 110, LLC. dba Leader	1 BOTTLE in 1 CARTON (70000-0474-1) / 118 mL in 1 BOTTLE	January 3, 2020
70000-0473	70000-0473	Cardinal Health 110, LLC. dba Leader	—	January 23, 2020
70000-0474	70000-0474	Cardinal Health 110, LLC. dba Leader	—	December 4, 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 · 10 sections on this page.