NDC 62011-0354 Health Mart Allergy And Congestion

Loratadine, Pseudoephedrine Sulfate

NDC Product Code 62011-0354

NDC Code: 62011-0354

Proprietary Name: Health Mart Allergy And Congestion 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: Loratadine, Pseudoephedrine Sulfate 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.


Product Characteristics
Color(s):
WHITE (C48325 - TO OFF-WHITE)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
7U0
Score: 1

Code Structure
  • 62011 - Mckesson
    • 62011-0354 - Health Mart Allergy And Congestion

NDC 62011-0354-1

Package Description: 20 BLISTER PACK in 1 CARTON > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Health Mart Allergy And Congestion with NDC 62011-0354 is a a human over the counter drug product labeled by Mckesson. The generic name of Health Mart Allergy And Congestion is loratadine, pseudoephedrine sulfate. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: Mckesson

Dosage Form: Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.

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.


Health Mart Allergy And Congestion 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.

  • LORATADINE 5 mg/1
  • PSEUDOEPHEDRINE SULFATE 120 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE (UNII: FZ989GH94E)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mckesson
Labeler Code: 62011
FDA Application Number: ANDA076050 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: 03-05-2019 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: 12-31-2020 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.

Health Mart Allergy And Congestion Product Label Images

Health Mart Allergy And Congestion 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 Ingredients (In Each Tablet)

Loratadine 5 mgPseudoephedrine sulfate 120 mg

Purpose

AntihistamineNasal decongestant

Uses

  • •temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: •sneezing •itchy, watery eyes •runny nose •itching of the nose or throat •temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies •reduces swelling of nasal passages •temporarily relieves sinus congestion and pressure •temporarily restores freer breathing through the nose

Do Not Use

  • •if you have ever had an allergic reaction to this product or any of its ingredients •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • •heart disease •thyroid disease •high blood pressure •diabetes •trouble urinating due to an enlarged prostate gland •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. •symptoms do not improve within 7 days or are accompanied by a fever •nervousness, dizziness or sleeplessness occurs

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

  • •do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet every 12 hours; not more than 2 tablets in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Other Information

  • •each tablet contains: calcium 25 mg •do not use if blister unit is broken or torn •store between 20° to 25°C (68° to 77°F) •keep in a dry place

Inactive Ingredients

Croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

* Please review the disclaimer below.

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