NDC 50580-242 Sudafed Sinus Congestion 12 Hour

Pseudoephedrine Hydrochloride

NDC Product Code 50580-242

NDC Code: 50580-242

Proprietary Name: Sudafed Sinus Congestion 12 Hour 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):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
19 MM
Imprint(s):
SU12
Score: 1

NDC Code Structure

  • 50580 - Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
    • 50580-242 - Sudafed Sinus Congestion 12 Hour

NDC 50580-242-01

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

NDC 50580-242-02

Package Description: 2 BLISTER PACK in 1 CARTON > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC 50580-242-03

Package Description: 3 CARTON in 1 PACKAGE > 1 BLISTER PACK in 1 CARTON > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Sudafed Sinus Congestion 12 Hour with NDC 50580-242 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The generic name of Sudafed Sinus Congestion 12 Hour is pseudoephedrine hydrochloride. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division

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.

Sudafed Sinus Congestion 12 Hour 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 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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • 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: Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
Labeler Code: 50580
FDA Application Number: ANDA075153 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: 06-17-2019 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.

Sudafed Sinus Congestion 12 Hour Product Label Images

Sudafed Sinus Congestion 12 Hour 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

Active Ingredient (In Each Tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal 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.

Ask A Doctor Before Use If You Have

  • Heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate gland

Otc - When Using

When using this product do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occursymptoms 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • Adults and children 12 years and overtake 1 tablet every 12 hoursdo not take more than 2 tablets in 24 hourschildren under 12 yearsdo not use this product in children under 12 years of age

Other Information

  • Each tablet contains: calcium 45 mgstore at 20-25°C (68-77°F) in a dry placeprotect from lightdo not use if blister unit is torn or brokensee carton end panel for lot number and expiration datethis product meets the requirements of USP Drug Release Test 3

Inactive Ingredients

Carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

* Please review the disclaimer below.

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