NDC 36800-241 Topcare All Day Allergy

Levocetirizine Dihydrochloride

NDC Product Code 36800-241

NDC CODE: 36800-241

Proprietary Name: Topcare All Day Allergy 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.

Non-Proprietary Name: Levocetirizine Dihydrochloride 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. It is also used to relieve itching and hives. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Levocetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). If your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use levocetirizine in place of your epinephrine.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
8 MM
Imprint(s):
L9CZ;5
Score: 2

NDC Code Structure

NDC 36800-241-01

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

NDC 36800-241-46

Package Description: 10 BLISTER PACK in 1 CARTON > 1 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Topcare All Day Allergy with NDC 36800-241 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare All Day Allergy is levocetirizine dihydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Topco Associates Llc

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc Drug 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.

Topcare All Day Allergy Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1

Inactive Ingredient(s)

About the 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.

  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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.

Labeler Name: Topco Associates Llc
Labeler Code: 36800
FDA Application Number: ANDA211983 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 02-05-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Topcare All Day Allergy Product Label Images

Topcare All Day Allergy Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

Levocetirizine dihydrochloride 5 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other respiratory allergies: •runny nose •itchy, watery eyes •sneezing •itching of the nose or throat

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 A 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-feeding: 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 doctoradults 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 •½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptomschildren 6-11 years of age •take ½ tablet (2.5 mg) once daily in the evening •do not take more than ½ tablet (2.5 mg) in 24 hourschildren under 6 years of age •do not useconsumers with kidney disease •do not use

Other Information

  • •store between 20° and 25°C (68° and 77°F) •do not use if blister unit is broken or torn

Inactive Ingredients

Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

* Please review the disclaimer below.