NDC 0031-8655 Robitussin 12 Hour Cough Relief
Dextromethorphan Polistirex Suspension, Extended Release Oral
Product Information
What is NDC 0031-8655?
The NDC code 0031-8655 is assigned by the FDA to the product Robitussin 12 Hour Cough Relief which is 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 product is distributed in a single package with assigned NDC code 0031-8655-10 1 bottle in 1 carton / 89 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Robitussin 12 Hour Cough Relief?
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) |
Product Details
What are Robitussin 12 Hour Cough Relief Active Ingredients?
- DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
Robitussin 12 Hour Cough Relief Active Ingredients UNII Codes
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
- RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
- RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
- RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension
Robitussin 12 Hour Cough Relief Inactive Ingredients UNII Codes
- 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)
Pharmacologic Class(es)
* Please review the disclaimer below.
Patient Education
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...
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* Please review the disclaimer below.
Robitussin 12 Hour Cough Relief Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- ALLERGY ALERT
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTHER
- PRINCIPAL DISPLAY PANEL
Otc - Active Ingredient
Active ingredient (in each 5 mL)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP
Otc - Purpose
Purpose
Cough 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 = milliliter
adults and children 12 years of age and over | 10 mL every 12 hours, not to exceed 20 mL in 24 hours |
children 6 to under 12 years of age | 5 mL every 12 hours, not to exceed 10 mL in 24 hours |
children 4 to under 6 years of age | 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours |
children under 4 years of age | do 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
Principal Display Panel
Robitussin®
EXTENDED-RELEASE
12 Hour
Cough Relief
DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)
12 Hour
Cough Relief
DAY or NIGHT
Orange
Flavored Liquid
Alcohol-Free
3 FL OZ (89 mL)
Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions
NEW SIZE!
Robitussin®
EXTENDED-RELEASE
12 Hour
Cough Relief
DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)
12 Hour
Cough Relief
DAY or NIGHT
Orange
Flavored Liquid
Alcohol-Free
5 FL OZ
(148 mL)
Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions
Robitussin®
EXTENDED-RELEASE
12 Hour
Cough Relief
DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)
12 Hour
Cough Relief
DAY or NIGHT
Grape
Flavored Liquid
Alcohol-Free
3 FL OZ (89 mL)
Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions
NEW SIZE!
Robitussin®
EXTENDED-RELEASE
12 Hour
Cough Relief
DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)
12 Hour
Cough Relief
DAY or NIGHT
Grape
Flavored Liquid
Alcohol-Free
5 FL OZ
(148 mL)
Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions
* Please review the disclaimer below.