NDC 37808-427 Loratadine And Pseudoephedrine Sulfate

Loratadine And Pseudoephedrine Sulfate

NDC Product Code 37808-427

NDC CODE: 37808-427

Proprietary Name: Loratadine And Pseudoephedrine Sulfate 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 And 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 - WHITE TO OFF-WHITE)
Shape: CAPSULE (C48336)
Size(s):
17 MM
Imprint(s):
RX724
Score: 1

NDC Code Structure

  • 37808 - Heb
    • 37808-427 - Loratadine And Pseudoephedrine Sulfate

NDC 37808-427-69

Package Description: 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Loratadine And Pseudoephedrine Sulfate with NDC 37808-427 is a a human over the counter drug product labeled by Heb. The generic name of Loratadine And Pseudoephedrine Sulfate is loratadine and pseudoephedrine sulfate. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: Heb

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.

Loratadine And Pseudoephedrine Sulfate 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 10 mg/1
  • PSEUDOEPHEDRINE SULFATE 240 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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • TALC (UNII: 7SEV7J4R1U)
  • 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: Heb
Labeler Code: 37808
FDA Application Number: ANDA076557 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: 02-01-2018 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 - NO 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".

* Please review the disclaimer below.

Loratadine And Pseudoephedrine Sulfate Product Label Images

Loratadine And Pseudoephedrine Sulfate 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

Other

Drug Facts

Otc - Purpose

Active ingredients (in each tablet)PurposeLoratadine, USP 10 mgAntihistaminePseudoephedrine sulfate, USP 240 mgNasal decongestant

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitchy, watery eyesrunny noseitching of the nose or throatreduces swelling of nasal passagestemporarily relieves sinus congestion and pressuretemporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergiestemporarily restores freer breathing through the nose

Do Not Use

  • If you have ever had an allergic reaction to this product or any of its ingredientsIf 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 diseasethyroid diseasehigh blood pressurediabetestrouble urinating due to an enlarged prostate glandliver or kidney disease. Your doctor should determine if you need a different dose.

Otc - When Using

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 fevernervousness, dizziness or sleeplessness occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Other Information

  • Sodium: contains 10 mg/tabletcalcium: contains 25 mg/tabletTAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.store between 20° C to 25° C (68° F to 77° F).protect from light and store in a dry place

Inactive Ingredients

Calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

Questions?

Call 1-800-406-7984

* Please review the disclaimer below.