NDC 71598-001 Robo Cough

Dextromethorphan Hbr

NDC Product Code 71598-001

NDC Product Information

Robo Cough with NDC 71598-001 is a a human over the counter drug product labeled by Dxm Pharmaceutical, Inc.. The generic name of Robo Cough is dextromethorphan hbr. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Dxm Pharmaceutical, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Robo Cough 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 30 mg/3mL

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.

  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

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: Dxm Pharmaceutical, Inc.
Labeler Code: 71598
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: 06-01-2019 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.

Robo Cough Product Label Images

Robo Cough 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 - Purpose

In each 3ml (one dose)Dextromethrophan HBr 30 mg......................cough suppressant

Indications & Usage

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

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.

Otc - Ask Doctor

  • Ask a doctor before use if you have a cough that is accompanied by excessive phlegm (mucus), or a persisten or chronic cough such as occurs with smoking, asthma, or emphysema.

Otc - Stop Use

Stop use and ask a doctor if​ a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Otc - Pregnancy Or Breast Feeding

​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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Dosage & Administration

  • ​Directions​only use this product according to these directions or as directed by a doctor. do not exceed 120 milligrams in any 24-hour period measure only 3mL with dosing cup provided keep dosing cup with product mL= milliliter this adult product is not intented for use in children under 12 years of age.age doseadults and children 12 years and over3mL every 6 to 8 hourschildren under 12 yearsdo not use

Storage And Handling

  • Other information​​store at 20-25* (68-77*F). Do not refrigerate.
  • TAMPER EVIDENT: Do not use if printed shrink band on bottle is broken or missing.

Inactive Ingredient

​Inactive ingredients​ high fructose corn syrup, phosphoric acid, propylene glycol, purified water, sodium benzoate (preservative), sucralose

Otc - Questions

​Questions or comments?​Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.RoboCough.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.

Otc - Active Ingredient

Dextromethorphan HBr........30mg

* Please review the disclaimer below.

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