NDC 51660-527 Allergy Relief
Loratadine Tablet, Orally Disintegrating Oral

Product Information

Allergy Relief is a human over the counter drug product labeled by Ohm Laboratories Inc.. The generic name of Allergy Relief is loratadine. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

Product Code51660-527
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.
Allergy Relief
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 FormTablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
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.
Ohm Laboratories Inc.
Labeler Code51660
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.
ANDA077153
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.
08-31-2007
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

What are the uses for Allergy Relief?


Product Characteristics

Color(s)WHITE (C48325 - WHITE TO OFF-WHITE)
ShapeROUND (C48348)
Size(s)10 MM
Imprint(s)RC17
Score1
Flavor(s)STRAWBERRY (C73417)
TUTTI FRUTTI (C73420)
MINT (C73404)

Product Packages

NDC 51660-527-31

Package Description: 30 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Price per Unit: $0.31111 per EA

Product Details

What are 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 10 mg/1 - A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.

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.
  • MANNITOL (UNII: 3OWL53L36A)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • ASPARTAME (UNII: Z0H242BBR1)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

* 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.

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



Active Ingredient (In Each Tablet)



Loratadine USP, 10 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



  • place 1 tablet on tongue; tablet disintegrates, with or without water
    adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of age ask a doctor
    consumers with liver or kidney disease ask a doctor

Other Information



  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • use tablet immediately after opening individual blister.

Inactive Ingredients



Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor


Questions?



Call 1-800-406-7984


Principal Display Panel



Compare To the active ingredient of Claritin® RediTabs®

NDC 51660-527-31

ohm®

Original Prescription Strength

NON-DROWSY*

Ages 6 years and older

Loratadine Orally Disintegrating Tablets USP, 10 mg

ANTIHISTAMINE

Allergy Relief

Indoor & Outdoor Allergies

No Water Needed

Melts in Your Mouth

24 HOUR

Relief of:

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat or Nose
  • 30 Orally Disintegrating Tablets

    *When taken as directed. See Drug Facts Panel.

    Distributed by: Ohm Laboratories Inc.

    5108363/R0314


* Please review the disclaimer below.