NDC 0031-8753 Robitussin 12 Hour Cough Relief

Dextromethorphan Polistirex

NDC Product Code 0031-8753

NDC 0031-8753-03

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

NDC Product Information

Robitussin 12 Hour Cough Relief with NDC 0031-8753 is a a human over the counter drug product labeled by Wyeth Consumer Healthcare 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.

Labeler Name: Wyeth Consumer Healthcare Llc

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.

  • DEXTROMETHORPHAN HYDROBROMIDE 30 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.

  • 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)
  • 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)
  • POLISTIREX (UNII: 5H9W9GTW27)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • 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.
  • 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: Wyeth Consumer Healthcare 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: 12-31-2020 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’.

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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 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

Other

Drug Facts

Distributed by: Pfizer, Madison, NJ 07940 USA

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 relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe 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 emphysemacough 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

  • Directionsshake bottle well before usemeasure only with dosing cup provided. Do not use dosing cup with other productsdose as follows or as directed by doctormL = 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 informationeach 5 mL contains: sodium 5 mgstore 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

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