Cvs Pharmacy, Inc. Children’s Allergy Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

ANDA Active Since 2018-06-20

Medication Information

Purpose

Antihistamine

Description

Loratadine 5 mg

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

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

Do Not Use

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

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

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).

Ask A Doctor Before Use If You Have

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

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)

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

Purpose

Antihistamine

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

Do Not Use (Do not use)

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

Other 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 (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? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

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).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Package/label Principal Display Panel (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)

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

Loratadine 5 mg

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTITOL", "unii": "D65DG142WK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine", "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients", "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", "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).", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose.", "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)", "Active ingredient (in each 5 mL teaspoonful)": "Loratadine 5 mg"}

Cvs Pharmacy, Inc. Children’s Allergy Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information