Children's Claritin Allergy (grape Flavor)

SPL v18

SPL

SPL Set ID 170061e9-e529-4ff0-e054-00144ff8d46c

Route

ORAL

Published

Effective Date 2015-05-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Sorbitol Edetate Disodium Maltitol Glycerin Phosphoric Acid Sucralose Water Sodium Phosphate, Monobasic Propylene Glycol Sodium Benzoate

Identifiers & Packaging

Marketing Status

NDA Active Since 2015-05-26

Description

Loratadine 5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine 5 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

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

Section 50570-1

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

Section 51727-6

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 60561-8

each 5 mL contains: sodium 6 mg
do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on top and bottom flaps of carton is not intact.
store between 20° and 25°C (68° and 77°F)

Directions

Use only with enclosed dosing cup

adults and children 6 years and over: 10 mL daily; do not take more than 10 mL in 24 hours
children 2 to under 6 years of age: 5 mL daily; do not take more than 5 mL in 24 hours
children under 2 years of age: ask a doctor
consumers with liver or kidney disease: ask a doctor

Questions Or Comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Active Ingredient (in Each 5 Ml Teaspoonful)

Loratadine 5 mg

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 60561-8 (60561-8)

each 5 mL contains: sodium 6 mg
do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on top and bottom flaps of carton is not intact.
store between 20° and 25°C (68° and 77°F)

Purpose

Antihistamine

Directions

Use only with enclosed dosing cup

adults and children 6 years and over: 10 mL daily; do not take more than 10 mL in 24 hours
children 2 to under 6 years of age: 5 mL daily; do not take more than 5 mL in 24 hours
children under 2 years of age: ask a doctor
consumers with liver or kidney disease: ask a doctor

Questions Or Comments? (Questions or comments?)

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Loratadine 5 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "51727-6": "edetate disodium, flavor, glycerin, maltitol, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "60561-8": "each 5 mL contains : sodium 6 mg do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on top and bottom flaps of carton is not intact. store between 20° and 25°C (68° and 77°F)", "Purpose": "Antihistamine", "Directions": "Use only with enclosed dosing cup adults and children 6 years and over: 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age: 5 mL daily; do not take more than 5 mL in 24 hours children under 2 years of age: ask a doctor consumers with liver or kidney disease: ask a doctor", "Questions or comments?": "1-800-CLARITIN (1-800-252-7484) or www.claritin.com", "Active ingredient (in each 5 mL teaspoonful)": "Loratadine 5 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:08.528700 · Updated: 2026-03-14T23:08:44.584027