Childrens Allergy

Label at a glance#

Contacts and useful links#

PhonePoison Help1800-222-1222

PhoneLabel contact1-248-449-9300

Websitewww.qualitychoice.comwww.qualitychoice.com

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

• use only with enclosed dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 ML) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours
children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) once dailly. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (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

STORAGE AND HANDLING SECTION

• store between 20º-25ºC (68º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glacial acetic acid, grape flavr, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

SPL UNCLASSIFIED SECTION

*Compare to the active ingredient in Children's Zyrtec®

Children's Allergy

Indoor & Outdoor Allergies

Cetirizine Oral Solution

1mg/mL | Antihistamine

24-Hour relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose

For Ages 2 Years & Older

Dye-free

Grape Flavor

Dosing Cup Included

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Zyrtec®

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Dosing cup should be washed and left to air dry after each use

Distributed by C.D.M.A Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Childrens Allergy
• Cetirizine HCl
• CETIRIZINE HYDROCHLORIDE
• CETIRIZINE
• ACETIC ACID
• GLYCERIN
• METHYLPARABEN
• PROPYLENE GLYCOL
• PROPYLPARABEN
• WATER
• SODIUM ACETATE
• SUCROSE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 428 matching rows.

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.