NDC 63102-104 Actinel Dm

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

NDC Product Code 63102-104

NDC 63102-104-16

Package Description: 474 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Actinel Dm with NDC 63102-104 is a a human over the counter drug product labeled by Actipharma, Inc. The generic name of Actinel Dm is dextromethorphan hbr, guaifenesin, phenylephrine hcl. The product's dosage form is solution and is administered via oral form.

Labeler Name: Actipharma, Inc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Actinel Dm 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.

  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5mL
  • GUAIFENESIN 400 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Actipharma, Inc
Labeler Code: 63102
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: 05-20-2019 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.

Actinel Dm Product Label Images

Actinel Dm 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 Ingredients (In Each 5 Ml Tsp)

Dextromethorphan HBr, USP.....20 mgGuaifenesin, USP......................400 mgPhenylephrine HCl, USP............10 mg

Purpose

Cough SuppressantExpectorantNasal Decongestant

Uses

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • Temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation.

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 • diabetes • heart disease • thyroid disease • high blood pressure • 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.When using this product • do not exceed recommended dosageStop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, come back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Do not take more than 6 doses in any 24-hour period. Adults and Children 12 years of age and over 5mL (1tsp), every 4 hours Children under 12 years of age ask a doctor

Other Information

• Store at room temperature 15°- 30°C (59°- 86°F) • protect from freezing • protect from light • Avoid excessive heat or humidity. TAMPER EVIDENT: Do not use if inner seal is torn, broken or missing. Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP.

Inactive Ingredients:

Artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate and sucralose.

* Please review the disclaimer below.

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