NDC 0031-8741 Robitussin Lingering Cold Long-acting Coughgels

Dextromethorphan Hbr

NDC Product Code 0031-8741

NDC CODE: 0031-8741

Proprietary Name: Robitussin Lingering Cold Long-acting Coughgels 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 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Product Characteristics

Color(s):
RED (C48326 - CLEAR RED)
Shape: OVAL (C48345)
Size(s):
10 MM
Imprint(s):
R
Score: 1

NDC Code Structure

  • 0031 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc
    • 0031-8741 - Robitussin Lingering Cold Long-acting Coughgels

NDC 0031-8741-20

Package Description: 1 BOTTLE in 1 BLISTER PACK > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Robitussin Lingering Cold Long-acting Coughgels with NDC 0031-8741 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Robitussin Lingering Cold Long-acting Coughgels is dextromethorphan hbr. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Robitussin Lingering Cold Long-acting Coughgels 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 15 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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MANNITOL (UNII: 3OWL53L36A)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K12 (UNII: 333AG72FWJ)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0031
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: 06-06-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 06-01-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]

* Please review the disclaimer below.

Robitussin Lingering Cold Long-acting Coughgels Product Label Images

Robitussin Lingering Cold Long-acting Coughgels 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

Other

Drug Facts

Active Ingredient (In Each Liquid-Filled Capsule)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Use

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

Otc - Do Not Use

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 havea cough that occurs with too much phlegm (mucus)a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Otc - Stop Use

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. These could be signs 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.

Directions

  • Do not take more than 8 capsules in any 24-hour periodthis adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and overtake 2 capsules every 6 to 8 hours, as neededchildren under 12 yearsdo not use

Other Information

  • Store at 20-25°C (68-77°F)avoid excessive heat above 40°C (104°F)protect from light

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, fractionated coconut oil, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol, sorbitol anhydrides

* Please review the disclaimer below.