American Sales Company Children’s Allergy Relief Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose

Identifiers & Packaging

Marketing Status

ANDA Active Since 2016-06-23 Until 2025-06-12

Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 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

Directions

•
use only with enclosed dosing cup
•
find right dose on chart below
•
mL = milliliter

adults and children 6 years and over	5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over	5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age	2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give 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

Do Not Use

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

Other Information

•
store between 20° to 25°C (68° to 77°F)
•
do not use if carton is opened, or if printed neckband is broken or missing
•
see bottom panel for lot number and expiration date

Inactive Ingredients

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments?

1-800-719-9260

When Using This Product

•
drowsiness may occur
•
avoid alcoholic drinks
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
be careful when driving a motor vehicle or operating machinery

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 breast-feeding: not recommended
•
if pregnant: 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)

Active Ingredient (in Each 5 Ml)

Cetirizine HCl 5 mg

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

CAREone^®

Compare to the active ingredient in Children’s Zyrtec^®

SUGAR FREE

For Ages 2 Years and Older

Children’s Allergy Relief

Cetirizine Hydrochloride Oral Solution 1mg/mL Antihistamine

dosing cup included

Grape Flavored

24hr

24-HOUR RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

• Indoor & Outdoor Allergies

• Dye Free

• Gluten Free

4 FL OZ (118mL)

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

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

Purpose

Antihistamine

Directions

•
use only with enclosed dosing cup
•
find right dose on chart below
•
mL = milliliter

adults and children 6 years and over	5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over	5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age	2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give 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

Do Not Use (Do not use)

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

Other Information (Other information)

•
store between 20° to 25°C (68° to 77°F)
•
do not use if carton is opened, or if printed neckband is broken or missing
•
see bottom panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)

•
drowsiness may occur
•
avoid alcoholic drinks
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
be careful when driving a motor vehicle or operating machinery

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:)

•
if breast-feeding: not recommended
•
if pregnant: 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)

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

Cetirizine HCl 5 mg

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)

CAREone^®

Compare to the active ingredient in Children’s Zyrtec^®

SUGAR FREE

For Ages 2 Years and Older

Children’s Allergy Relief

Cetirizine Hydrochloride Oral Solution 1mg/mL Antihistamine

dosing cup included

Grape Flavored

24hr

24-HOUR RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

• Indoor & Outdoor Allergies

• Dye Free

• Gluten Free

4 FL OZ (118mL)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "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 SOLUTION", "unii": "8KW3E207O2", "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 • sneezing • itchy, watery eyes • itching of the nose or throat", "Purpose": "Antihistamine", "Directions": "• use only with enclosed dosing cup • find right dose on chart below • mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give 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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.", "Other information": "• store between 20° to 25°C (68° to 77°F) • do not use if carton is opened, or if printed neckband is broken or missing • see bottom panel for lot number and expiration date", "Inactive ingredients": "anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose", "Questions or comments?": "1-800-719-9260", "When using this product": "• drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery", "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 breast-feeding: not recommended • if pregnant: 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)", "Active ingredient (in each 5 mL)": "Cetirizine HCl 5 mg", "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": "CAREone ® Compare to the active ingredient in Children’s Zyrtec ® SUGAR FREE For Ages 2 Years and Older Children’s Allergy Relief Cetirizine Hydrochloride Oral Solution 1mg/mL Antihistamine dosing cup included Grape Flavored 24hr 24-HOUR RELIEF OF: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose • Indoor & Outdoor Allergies • Dye Free • Gluten Free 4 FL OZ (118mL)", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives."}

American Sales Company Children’s Allergy Relief Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information