leader childrens allergy relief

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2021-06-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:52

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

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.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

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

Inactive ingredients

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

Package/Label Principal Display Panel

Non-Drowsy* Children’s Allergy Relief Loratadine Oral Solution USP, 5 mg/5 mL | Antihistamine Indoor and Outdoor Allergies Grape Flavor 24 Hour Relief of: Sneezing Runny Nose; Itchy, Watery Eyes Itchy Throat or Nose Sugar-Free Alcohol-Free Dye-Free COMPARE TO CHILDREN’S CLARITIN ® active ingredient Ages 2 Years and Older 100% Money Back Guarantee *When Taken As Directed. See Drug Facts Panel. 4 FL OZ (120 mL)

Label Images

6t5-e9-allergy-relief
6t5-e9-allergy-relief

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

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-Drowsy* Children’s Allergy Relief Loratadine Oral Solution USP, 5 mg/5 mL | Antihistamine Indoor and Outdoor Allergies Grape Flavor 24 Hour Relief of: Sneezing Runny Nose; Itchy, Watery Eyes Itchy Throat or Nose Sugar-Free Alcohol-Free Dye-Free COMPARE TO CHILDREN’S CLARITIN ® active ingredient Ages 2 Years and Older 100% Money Back Guarantee *When Taken As Directed. See Drug Facts Panel. 4 FL OZ (120 mL)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/20b438e1-f461-48fa-b007-4c02ecb91b68/dcec05fa-b447-436b-ac94-01c75b950693.xml
XML SHA-256
03f2f0d9543855e280528722cd60544ef974bc151a95c704f0cf63d000a68012
XML bytes
23393

Legacy File Index

FolderFileDate
otcdcec05fa-b447-436b-ac94-01c75b950693.xml2021-06-18
otc20b438e1-f461-48fa-b007-4c02ecb91b68.xml2020-01-24
otc6t5-e9-allergy-relief.jpg2020-01-24