NDC 0031-8655 Robitussin 12 Hour Cough Relief

Dextromethorphan Polistirex

  1. Labeler Index
  2. Glaxosmithkline Consumer Healthcare Holdings (us) Llc
  3. NDC: 0031-8655 Robitussin 12 Hour Cough Relief

NDC Product Code 0031-8655

NDC CODE: 0031-8655

Proprietary Name: Robitussin 12 Hour Cough Relief 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 Polistirex 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):
ORANGE (C48331)
Flavor(s):
ORANGE (C73406)

NDC Code Structure

  • 0031 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0031-8655-10

Package Description: 1 BOTTLE in 1 CARTON > 89 mL in 1 BOTTLE

NDC Product Information

Robitussin 12 Hour Cough Relief with NDC 0031-8655 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Robitussin 12 Hour Cough Relief is dextromethorphan polistirex. The product's dosage form is suspension, extended release and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1373045.

Dosage Form: Suspension, Extended Release - A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).

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 12 Hour Cough Relief 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.

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.
  • POLISTIREX (UNII: 5H9W9GTW27)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYVINYL ACETATE (UNII: 32K497ZK2U)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
  • SUCROSE (UNII: C151H8M554)
  • TARTARIC ACID (UNII: W4888I119H)
  • TRAGACANTH (UNII: 2944357O2O)
  • TRIACETIN (UNII: XHX3C3X673)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: ANDA091135 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 07-01-2015 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: 12-31-2022 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 - 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]

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Robitussin 12 Hour Cough Relief Product Label Images

Robitussin 12 Hour Cough Relief 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 5 mL)Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Otc - Purpose

PurposeCough suppressant

Indications & Usage

  • Uses temporarily relieves •cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants •the impulse to cough to help you get to sleep

Warnings

Warnings

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.

Allergy Alert

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

  • •side effects occur. You may report side effects to FDA at 1-800-FDA-1088. •cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. 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 1-800-222-1222.

Dosage & Administration

  • Directions •shake bottle well before use •measure only with dosing cup provided. Do not use dosing cup with other products •dose as follows or as directed by doctor •mL = milliliteradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use

Storage And Handling

  • Other information •each 5 mL contains: sodium 5 mg •store at 20-25°C (68-77°F) •dosing cup provided

Inactive Ingredient

Inactive ingredients (Grape flavor)D&C red no. 30, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Inactive ingredients (Orange flavor)D&C red no. 30, D&C yellow no. 10, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Otc - Questions

Questions?call weekdays from 9 AM to 5 PM EST at 1-800-762-4675.You may also report side effects to this number.For most recent product information, visit www.robitussin.com

Other

Distributed by: Pfizer, Madison, NJ 07940 USA

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