NDC 0904-6727 Pseudoephedrine Hydrochloride

Pseudoephedrine Hydrochloride

NDC Product Code 0904-6727

NDC Code: 0904-6727

Proprietary Name: Pseudoephedrine Hydrochloride 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: Pseudoephedrine Hydrochloride 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):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
1004
Score: 1

NDC Code Structure

  • 0904 - Major Pharmaceuticals

NDC 0904-6727-60

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Pseudoephedrine Hydrochloride with NDC 0904-6727 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Pseudoephedrine Hydrochloride is pseudoephedrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Pseudoephedrine Hydrochloride 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.

  • PSEUDOEPHEDRINE HYDROCHLORIDE 30 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SUCROSE (UNII: C151H8M554)
  • KAOLIN (UNII: 24H4NWX5CO)
  • CALCIUM CATION (UNII: 2M83C4R6ZB)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SHELLAC (UNII: 46N107B71O)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GELATIN (UNII: 2G86QN327L)
  • TALC (UNII: 7SEV7J4R1U)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)

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: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: part341 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-31-2019 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.

Pseudoephedrine Hydrochloride Product Label Images

Pseudoephedrine Hydrochloride 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

Drug Facts

Active ingredient (in each tablet)Pseudoephedrine HCl 30 mg

Otc - Purpose

PurposeNasal decongestant

Uses

  • Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergiestemporarily relieves sinus congestion and pressure

Otc - Do Not Use

Do not use 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.

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart disease high blood pressurethyroid disease diabetes trouble urinating due to an enlarged prostate gland

Otc - When Using

When using this product do not exceed recommended dose.

Otc - Stop Use

  • Stop use and ask a doctor ifnervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

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.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take every 4-6 hours do not take more than 4 doses in 24 hoursadults & children 12 years & over2 tablets children 6 to under 12 years1 tabletschildren under 6 yearsdo not use

Other Information

  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Inactive Ingredient

Calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar, titanium dioxide

Other

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Sudafed®.TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDistributed by:
MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

* Please review the disclaimer below.