NDC 65193-325 Pseudo Ephed Plus

Pseudoephedrine Hydrochloride, Guaifenesin

NDC Product Code 65193-325

NDC Code: 65193-325

Proprietary Name: Pseudo Ephed Plus Additional informationCallout TooltipWhat 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, Guaifenesin Additional informationCallout TooltipWhat 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 - SNOW WHITE)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
EP230
Score: 1

Code Structure
  • 65193 - Dickey Consumer Products Dba Dmd
    • 65193-325 - Pseudo Ephed Plus

NDC 65193-325-24

Package Description: 24 TABLET in 1 BLISTER PACK

NDC Product Information

Pseudo Ephed Plus with NDC 65193-325 is a a human over the counter drug product labeled by Dickey Consumer Products Dba Dmd. The generic name of Pseudo Ephed Plus is pseudoephedrine hydrochloride, guaifenesin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Dickey Consumer Products Dba Dmd

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

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Pseudo Ephed Plus Active Ingredient(s)

Additional informationCallout TooltipWhat 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
  • GUAIFENESIN 200 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • POVIDONE K30 (UNII: U725QWY32X)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dickey Consumer Products Dba Dmd
Labeler Code: 65193
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-15-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Pseudo Ephed Plus Product Label Images

Pseudo Ephed Plus 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

Otc - Active Ingredient

Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg

Otc - Purpose

Purposes - Nassal Decongestant, Expectorant

Indications & Usage

• temporarily relieves nasal congestion due to the common cold • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

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 disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • a cough accompanied by excessive phlegm (mucus)When using this product • do not use more than directed • intentional abuse of this product can be harmful or fatalStop use and ask a doctor if: • you get nervous dizzy or sleepless • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. • symptoms do not get better within 7 days or occur with a fever

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health proffessional 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.

Dosage & Administration

• adults and children 12 years of age and over: take 2 tablets every 4 to 6 hours; do not exceed 8 tablets in 24 hours • children under 12 years of age: ask a doctor

Inactive Ingredient

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid

* Please review the disclaimer below.

Previous Code
65193-320
Next Code
65193-340