Major Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts

Manufacturer
Major Pharmaceuticals
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:03

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

Uses

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

Warnings

Directions And Dosage

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 Label Information

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?

1-800-719-9260

Package/Label Principal Display Panel

MAJOR ® 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 dosing cup included 4 fl oz (120 mL)

Label Images

major-childrens-loratadine-oral-solution-carton-image
major-childrens-loratadine-oral-solution-carton-image

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR ® 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 dosing cup included 4 fl oz (120 mL)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otcefdb406d-9562-4ed6-b461-683c82e26a73.xml2025-11-15
otcmajor-childrens-loratadine-oral-solution-carton-image.jpg2025-11-15
otc62485dc6-96e4-4449-99d3-598c92dc2930.xml2025-05-07
otcmajor-childrens-loratadine-grape-carton-image.jpg2025-05-07
otcc1d82e33-5de9-40b0-8e03-be47e98c466c.xml2020-09-02
otcimage-01.jpg2020-09-02
otc3f0f0131-b516-4ff3-8049-3d3766324b66.xml2019-03-12
otc6T55C-childrens-loratadine-oral-solution.jpg2019-03-12