Childrens Allergy LORATADINE CVS PHARMACY FDA Approved 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
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Substance Loratadine
Route
ORAL
Applications
ANDA075728

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg
Inactive Ingredients
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
Strengths
5 ml 5 mg
Quantities
5 ml 120 ml
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
UNII
7AJO3BO7QN
Packaging

Package/Label Principal Display Panel CVS Health ® Compare to the active ingredient in Children’s Claritin ® Indoor & Outdoor Allergies Children’s Allergy 24 HOUR LORATADINE ORAL SOLUTION, 5 mg/5 mL (Antihistamine) ALLERGY Non-Drowsy † 24 hour relief of: Sneezing; Runny nose; Itchy, watery eyes; Itchy throat or nose Ages 2 yrs & older † When taken as directed. See Drug Facts Panel. DYE FREE Grape Flavor Dosage Cup Included Free of alcohol, sugar & gluten 4 FL OZ (120 mL) childrens allergy

Package Descriptions
  • Package/Label Principal Display Panel CVS Health ® Compare to the active ingredient in Children’s Claritin ® Indoor & Outdoor Allergies Children’s Allergy 24 HOUR LORATADINE ORAL SOLUTION, 5 mg/5 mL (Antihistamine) ALLERGY Non-Drowsy † 24 hour relief of: Sneezing; Runny nose; Itchy, watery eyes; Itchy throat or nose Ages 2 yrs & older † When taken as directed. See Drug Facts Panel. DYE FREE Grape Flavor Dosage Cup Included Free of alcohol, sugar & gluten 4 FL OZ (120 mL) childrens allergy

Overview

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

Indications & Usage

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

Dosage & Administration

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 & Precautions
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).
Purpose

Purpose Antihistamine

Do Not Use

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

When Using

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

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

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).

Storage & Handling

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)

Questions

Questions or comments? 1-800-719-9260


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