NDC 63868-093 Quality Choice Childrens Allergy Relief

Product Information

What is NDC 63868-093?

The NDC code 63868-093 is assigned by the FDA to the product Quality Choice Childrens Allergy Relief which is product labeled by Chain Drug Marketing Association Inc.. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 63868-093-08 1 bottle in 1 carton / 120 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code63868-093
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Quality Choice Childrens Allergy Relief
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Chain Drug Marketing Association Inc.
Labeler Code63868
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-08-2011
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2019
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Quality Choice Childrens Allergy Relief?


Product Characteristics

Color(s)YELLOW (C48330 - COLORLESS TO SLIGHTLY YELLOW)
Flavor(s)GRAPE (C73391)
BANANA (C73364)

Product Packages

NDC Code 63868-093-08

Package Description: 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Quality Choice Childrens Allergy Relief Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Quality Choice Childrens Allergy Relief Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Patient Education

Cetirizine

Cetirizine is pronounced as (se ti' ra zeen)

Why is cetirizine medication prescribed?
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dus...
[Read More]

* Please review the disclaimer below.

Quality Choice Childrens Allergy Relief Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995


Active Ingredient (In Each 5 Ml Teaspoonful)



Cetirizine HCl 5 mg


Purpose



Antihistamine


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

Otc - 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.


Otc - Ask Doctor



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


Otc - Ask Doctor/Pharmacist



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


Otc - When Using



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

Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding:

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

Otc - 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).


Directions



  • use only with enclosed dosing cup
  • adults and children 6 years and over1 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 older1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
    children 2 to under 6 years of age½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information



  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients



artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose


Questions?



Call 248-449-9300


Principal Display Panel - 120 Ml Bottle Carton



QC
QUALITY
CHOICE
®

NDC 63868-093-08

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

children's
Allergy
Relief

Cetirizine Hydrochloride
Oral Solution, 1 mg/mL
Antihistamine

Indoor & Outdoor
Allergies

24 Hour Relief of:
Runny Nose | Sneezing
Itchy, watery eyes
Itchy throat or nose

2 Yrs. & older

Sugar Free
Grape
Flavor

Dosing Cup
Included

4 FL OZ (120 mL)


* Please review the disclaimer below.