NDC 63868-092 Quality Choice Childrens Allergy Relief

Product Information

Quality Choice Childrens Allergy Relief is product labeled by Chain Drug Marketing Association, Inc.. The product's dosage form is and is administered via form.

Product Code63868-092
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.
02-27-2010
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)

Product Packages

NDC 63868-092-08

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

What are Quality Choice Childrens Allergy Relief Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • LORATADINE (UNII: 7AJO3BO7QN)
  • LORATADINE (UNII: 7AJO3BO7QN) (Active Moiety)

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:

Inactive Ingredient(s)

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.
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)

* Please review the disclaimer below.

Patient Education

Loratadine

Loratadine is pronounced as (lor at' a deen)

Why is loratadine medication prescribed?
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include ...
[Read More]

* Please review the disclaimer below.

Quality Choice Childrens Allergy Relief Labeling and Warnings

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.

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)



Loratadine 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.


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 - When Using



When using this product do not take more than directed. Taking more than directed may cause drowsiness.


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, 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 over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
    children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information



  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20° and 25°C (68° and 77°F)

Inactive Ingredients



glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.


Questions?



Call 248-449-9300


Principal Display Panel - 120 Ml Bottle Carton



NDC 63868-092-08

QC
QUALITY
CHOICE®

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

children's
Allergy
Relief

Loratadine
Oral Solution 5 mg/5 mL
Antihistamine

Indoor & Outdoor
Allergies

24 Hour Non-Drowsyt
Allergy Relief of:

Runny Nose | Sneezing
Itchy, watery eyes
Itchy throat or nose

Dosing Cup
Included

2 Yrs. & older

Sugar Free
Grape
Flavor

When taken as directed.
See Drug Facts Panel

4 FL OZ (120 mL)


* Please review the disclaimer below.