NDC 41250-204 Pseudoephedrine Hydrochloride

NDC Product Code 41250-204

NDC 41250-204-20

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

NDC 41250-204-69

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Pseudoephedrine Hydrochloride with NDC 41250-204 is a product labeled by Meijer Distribution, Inc.. The generic name of Pseudoephedrine Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Meijer Distribution, Inc.

Dosage Form: -

Product Type: 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.

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.

  • CASTOR OIL (UNII: D5340Y2I9G)
  • COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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

Labeler Name: Meijer Distribution, Inc.
Labeler Code: 41250
Start Marketing Date: 04-28-2006 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: 12-31-2019 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: I 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’.

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Information for Patients

Pseudoephedrine

Pseudoephedrine is pronounced as (soo doe e fed' rin)

Why is pseudoephedrine medication prescribed?
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseud...
[Read More]

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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

Active Ingredient (In Each Tablet)

Pseudoephedrine HCl USP, 120 mg

Purpose

Nasal decongestant

Uses

  • Temporarily relieves nasal congestion due to:common coldhay feverupper respiratory allergiestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainagetemporarily relieves sinus congestion and pressure

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 pressurediabetesthyroid diseasetrouble urinating due to an enlarged prostate gland

When Using This Product

  • Do not use more than directed

Stop Use And Ask A Doctor If

  • Symptoms do not get better within 7 days or occur with a feveryou get nervous, dizzy, or sleepless

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.

Directions

  • Adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hourschildren under 12 years: ask a doctor

Other Information

  • Store at 59° to 77° F in a dry placeprotect from lightTAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients

Castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

Questions?

Call 1-800-406-7984

* Please review the disclaimer below.