Robitussin 12 Hour Cough Relief
Dextromethorphan Polistirex
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0031-8753Robitussin 12 Hour Cough Relief also known as Dextromethorphan Polistirex is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Robitussin 12 Hour Cough Relief is 0031-8753. This drug is available in dosage form of Suspension, Extended Release. The names of the active, medicinal ingredients in Robitussin 12 Hour Cough Relief drug includes Dextromethorphan Hydrobromide - 30 mg/5mL . The currest status of Robitussin 12 Hour Cough Relief drug is Active.
Drug Information:
| Drug NDC: | 0031-8753 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Robitussin 12 Hour Cough Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dextromethorphan Polistirex |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension, Extended Release |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DEXTROMETHORPHAN HYDROBROMIDE - 30 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jul, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| 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. |
| Application Number: | ANDA091135 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1373045
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 9D2RTI9KYH
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0031-8753-03 | 1 BOTTLE in 1 CARTON (0031-8753-03) / 89 mL in 1 BOTTLE | 01 Jul, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose cough suppressant
Product Elements:
Robitussin 12 hour cough relief dextromethorphan polistirex dextromethorphan hydrobromide dextromethorphan polistirex d&c red no. 30 d&c yellow no. 10 glycerin high fructose corn syrup methylparaben polysorbate 80 polyvinyl acetate povidone, unspecified propylparaben sodium metabisulfite sodium polystyrene sulfonate sucrose tartaric acid tragacanth triacetin water xanthan gum robitussin 12 hour cough relief dextromethorphan polistirex dextromethorphan hydrobromide dextromethorphan polistirex d&c red no. 30 d&c yellow no. 10 glycerin high fructose corn syrup methylparaben polysorbate 80 polyvinyl acetate povidone, unspecified propylparaben sodium metabisulfite sodium polystyrene sulfonate sucrose tartaric acid tragacanth triacetin water xanthan gum robitussin 12 hour cough relief dextromethorphan polistirex dextromethorphan hydrobromide dextromethorphan polistirex d&c red no. 30 fd&c blue no. 1 glycerin high fructose corn syrup methylparaben polysorbate 80 polyvinyl acetate povidone, unspecified propylparaben sodium metabisulfite sodium polystyrene sulfonate sucrose tartaric acid tragacanth triacetin water xanthan gum robitussin 12 hour cough relief dextromethorphan polistirex dextromethorphan hydrobromide dextromethorphan polistirex d&c red no. 30 fd&c blue no. 1 glycerin high fructose corn syrup methylparaben polysorbate 80 polyvinyl acetate povidone, unspecified propylparaben sodium metabisulfite sodium polystyrene sulfonate sucrose tartaric acid tragacanth triacetin water xanthan gum
Indications and 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 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get med
Read more...ical help or contact a poison control center right away 1-800-222-1222.
Do Not Use:
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. 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. if pregnant or breast-feeding, ask a health professional before use. 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 and 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
Stop Use:
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.
Package Label Principal Display Panel:
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 robitussin 12 hr orange 3 fl oz(89 ml)
Principal display panel 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 12 hr orange 5 fl oz (148 ml)
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 grape flavored liquid alcohol-free 3 fl oz (89 ml) contains sodium metabisulfite, a sulfite that may cause allergic-type reactions robitussin 12 hr grape 3 fl oz (89 ml)
Principal display panel 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 robitussin 12 hr grape 5 fl oz (148 ml)
Further 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