NDC 65193-225 Ephed Plus

Ephedrine Hydrochloride, Guaifenesin

NDC Product Code 65193-225

NDC Code: 65193-225

Proprietary Name: Ephed Plus 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: Ephedrine Hydrochloride, Guaifenesin 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 - SNOW WHITE)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
EP225
Score: 4

NDC Code Structure

  • 65193 - Dickey Consumer Products Dba Dmd
    • 65193-225 - Ephed Plus

NDC 65193-225-24

Package Description: 24 TABLET in 1 BLISTER PACK

NDC Product Information

Ephed Plus with NDC 65193-225 is a a human over the counter drug product labeled by Dickey Consumer Products Dba Dmd. The generic name of Ephed Plus is ephedrine 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 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.

Ephed Plus 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.

  • EPHEDRINE HYDROCHLORIDE 25 mg/1
  • GUAIFENESIN 200 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.

  • 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)

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: Dickey Consumer Products Dba Dmd
Labeler Code: 65193
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: 04-02-2019 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.

Ephed Plus Product Label Images

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): Ephedrine HCl 25 mg, Guaifenesin 200 mg

Otc - Purpose

Purposes - Bronchodilator, Expectorant

Indications & Usage

• for temporary relief of mild symptoms of intermittent asthma: • wheezing • tightness of chest • shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive.

Warnings

Asthma Alert:  because asthma may be life threatening, see a doctor if you: • Are not better in 60 minutes • get worse • need more than 6 tablets in 24 hours • use more than 4 tablets in 24 hours for 3 or more days a week • have more than 2 asthma attacks in a week. These may be signs that your asthma is getting worse. This product will not give you relief as quickly as an inhaled bronchodilatorDo not use: • Unless a doctor said you have asthma • 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: • ever been hospitalized for asthma • heart disease • high blood pressure • diabetes • thyroid disease • seizures • narrow angle glaucoma • a psychiatric or emotional condition • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.Ask a doctor or pharmacist before use if you are: • taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.  Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)When using this product • your blood pressure or heart rate may go up.  This could increase your risk of heart attack or stroke, which may cause death.  • your risk of heart attack or stroke increases if you:• have a history of high blood pressure or heart disease • take this product more frequently or take more than the recommended dose.• avoid food or beverages that contain caffeine • Avoid dietary supplements containing ingredients reported or claim to have a stimulant effect.  Stop use and ask a doctor if: • your asthma is getting worse (see Asthma alert) • you have difficulty sleeping • you have a rapid heart beat • you have tremors, nervousness or seizures • cough lasts more than 1 week, comes back , or occurs with fever, rash, or persistent headache.  These could be signs of a serious condition.

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

• do not take more than directed • adults and children 12 years of age and over: 1 tablet every 4 hours as needed, do not take more than 6 tablets in 24 hours • children under 12 years of age: do not use

Inactive Ingredient

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

* Please review the disclaimer below.

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