NDC 0904-6767 Childrens Loratadine Oral
Loratadine Solution Oral

Product Information

Product Code0904-6767
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.
Childrens Loratadine Oral
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Loratadine
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Major Pharmaceuticals
Labeler Code0904
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ANDA075728
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
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.
02-12-2019
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.
12-31-2022
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".
N
NDC Code Structure

Usage Information


Product Characteristics

Flavor(s)GRAPE (C73391)

Product Packages

NDC 0904-6767-20

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

Price per Unit: $0.04343 per ML

Product Details

Childrens Loratadine Oral is a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Childrens Loratadine Oral is loratadine. The product's dosage form is solution and is administered via oral form.


What are Childrens Loratadine Oral Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is 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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MALTITOL (UNII: D65DG142WK)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)


* Please review the disclaimer below.

Childrens Loratadine Oral 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



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

Do Not Use



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


Ask A Doctor Before Use If You Have



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


When Using This Product



do not take more than directed. Taking more than directed may cause drowsiness.


Stop Use And Ask A Doctor If



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


If Pregnant Or Breast Feeding,



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).


Directions



  • •use only with enclosed dosing cup
  • adults and children 6 years and over

    2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours

    children 2 to under 6 years of age

    1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) 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 printed neckband is broken or missing
  • •store between 20° to 25°C (68° to 77°F)

Inactive Ingredients



edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to the active ingredient in Children’s Claritin®

Children’s

Loratadine

Oral Solution,

USP, 5 mg/5 mL

(Antihistamine) ALLERGY

Non-Drowsy†

Indoor & Outdoor Allergies

SUGAR FREE

Dye Free

24 HOUR

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Ages 2 years and older

Dosing Cup Enclosed

Grape Flavor

†When taken as directed. See Drug Facts Panel.

4 FL OZ

(120 mL)


* Please review the disclaimer below.