children's allergy

children's allergy
SPL v3
SPL
SPL Set ID 9a8b5af0-72bb-48d5-bb5e-0dc6808bf466
Route
oral
Published
Effective Date 2019-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetirizine (1 mg)
Inactive Ingredients
acetic acid glycerin methylparaben propylene glycol propylparaben water sodium acetate anhydrous sucralose

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
anda active Since 2011-05-20

Purpose

Antihistamine

Description

Drug Facts


Medication Information

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

Dosage and Administration
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
Other Information
  • do not use if carton is opened or if imprinted safety seal is broken or missing
  • see bottom panel for lot number and expiration date
  • store between 68° to 77°F (20° to 25°C)
Inactive Ingredients

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50566-9

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

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking tranquilizers or sedatives.

Section 50569-3

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

Section 50570-1

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

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
If Pregnant Or Breast Feeding
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each 5 Ml)

Cetirizine HCl 5 mg

Principal Display Panel 120 Ml Bottle Carton

NDC 56062-106-08

AGES 2 YEARS

AND OLDER

INDOOR & OUTDOOR

ALLERGIES

children's

allergy

CETIRIZINE HYDROCHLORIDE

ORAL SOLUTION, 1 mg/mL

ALLERGY

ANTIHISTAMINE

24-hour relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

DYE FREE

SUGAR FREE

BUBBLE GUM

FLAVOR

DOSING CUP

INCLUDED

4 FL OZ (120 mL)

*Compare to

the Active Ingredient

in Children's Zyrtec ®


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

Dosage and Administration (34068-7)
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
Other Information (Other information)
  • do not use if carton is opened or if imprinted safety seal is broken or missing
  • see bottom panel for lot number and expiration date
  • store between 68° to 77°F (20° to 25°C)
Inactive Ingredients (Inactive ingredients)

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

Section 42229-5 (42229-5)

Drug Facts

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 (1-800-222-1222).

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking tranquilizers or sedatives.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

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
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Cetirizine HCl 5 mg

Principal Display Panel 120 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton)

NDC 56062-106-08

AGES 2 YEARS

AND OLDER

INDOOR & OUTDOOR

ALLERGIES

children's

allergy

CETIRIZINE HYDROCHLORIDE

ORAL SOLUTION, 1 mg/mL

ALLERGY

ANTIHISTAMINE

24-hour relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

DYE FREE

SUGAR FREE

BUBBLE GUM

FLAVOR

DOSING CUP

INCLUDED

4 FL OZ (120 mL)

*Compare to

the Active Ingredient

in Children's Zyrtec ®


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)