NDC 70518-2126 Robafen Dm

Dextromethorphan Hbr, Guaifenesin

NDC Product Code 70518-2126

NDC Code: 70518-2126

Proprietary Name: Robafen Dm 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: Dextromethorphan Hbr, 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.

NDC Code Structure

  • 70518 - Remedyrepack Inc.
    • 70518-2126 - Robafen Dm

NDC 70518-2126-0

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Robafen Dm with NDC 70518-2126 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Robafen Dm is dextromethorphan hbr, guaifenesin. The product's dosage form is solution and is administered via oral form.

Labeler Name: Remedyrepack 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.

Robafen 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/10mL
  • GUAIFENESIN 200 mg/10mL

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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • MENTHOL (UNII: L7T10EIP3A)

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: Remedyrepack Inc.
Labeler Code: 70518
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: 05-31-2019 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.

Robafen Dm Product Label Images

Robafen 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 10 Ml)

Dextromethorphan HBr, USP 20 mgGuaifenesin, USP 200 mg

Purposes

Cough suppressantExpectorant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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

  • Cough that occurs with too much phlegm (mucus)
  • Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop Use And Ask A Doctor If

Cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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 (1-800-222-1222).

Directions

  • Do not take more than 6 doses in any 24-hour period
  • Measure only with dosing cup provided
  • Keep dosing cup with product
  • ML = milliliter
  • This adult product is not intended for use in children under 12 years of age
  • Agedoseadults and children12 years and over10 mLevery 4 hourschildren under 12 yearsdo not use

Other Information

  • Phenylketonurics:Contains Phenylalanine 30 mg per 10 mLstore at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

Aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water

* Please review the disclaimer below.

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