NDC 46122-531 Allergy Relief
Levocetirizine Dihydrochloride Tablet, Coated Oral

Product Information

Allergy Relief is a human over the counter drug product labeled by Amerisourcebergen Drug Corporation. The generic name of Allergy Relief is levocetirizine dihydrochloride. The product's dosage form is tablet, coated and is administered via oral form.

Product Code46122-531
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.
Levocetirizine Dihydrochloride
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, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
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.
Amerisourcebergen Drug Corporation
Labeler Code46122
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.
ANDA210375
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.
04-20-2018
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.
12-31-2023
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)
ShapeOVAL (C48345)
Size(s)9 MM
Imprint(s)L
Score2

Product Packages

NDC 46122-531-05

Package Description: 1 BOTTLE in 1 CARTON > 35 TABLET, COATED in 1 BOTTLE

Price per Unit: $0.17332 per EA

NDC 46122-531-52

Package Description: 2 BLISTER PACK in 1 CARTON > 5 TABLET, COATED in 1 BLISTER PACK

Price per Unit: $0.17332 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.

Allergy Relief Active Ingredients UNII Codes

  • LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA)
  • LEVOCETIRIZINE (UNII: 6U5EA9RT2O) (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:
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG Oral Tablet
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Levocetirizine

Levocetirizine is pronounced as (lee'' voe se tir' i zeen)

Why is levocetirizine medication prescribed?
Levocetirizine is used to relieve runny nose; sneezing; and redness, itching, and tearing of the eyes caused by hay fever, seasonal allergies, and allergies to other subs...
[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)



Levocetirizine dihydrochloride USP, 5 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings




Do Not Use



  • if you have kidney disease
  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask A Doctor Before Use If You Have



  • ever had trouble urinating or emptying your bladder

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 

Stop Use And Ask Doctor If



  • you have trouble urinating or emptying your bladder
  • an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding:



  • if breast-feding: not recommended
  • if pregnant: 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



adults 65 years of age and older
  • ask a doctor
adults and children 12-64 years of age
  • take 1 tablet (5 mg) once daily in the evening
  • do not take more than 1 tablet (5 mg) in 24 hours
  • 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age
  • take 1/2 tablet (2.5 mg) once daily in the evening
  • do not take more than 1/2 tablet (2.5 mg) in 24 hours
children under 6 years of age
  • do not use
consumers with kidney disease
  • do not use


Other Information



  • store between 20° and 25°C (68° and 77°F)
  • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

Inactive Ingredients



colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide


Questions Or Comments?



Call 1-888-375-3784


Carton Label



Compare to Xyzal® Allergy 24HR
active ingredient*

Good
Neighbor
Pharmacy®

NDC 46122-531-05

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief
levocetirizine dihydrochloride
tablets USP, 5 mg

Antihistamine

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy Nose or Throat
  • Itchy, Watery Eyes
  • 24 HOUR

    35 TABLETS


Bottle Label



Good
Neighbor
Pharmacy®

NDC 46122-531-05

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief
levocetirizine
dihydrochloride
tablets USP, 5 mg

Antihistamine

35 TABLETS 24 HOUR


* Please review the disclaimer below.