Childrens Robitussin Cough And Cold Long-acting
Chlorpheniramine Maleate, Dextrometrorphan Hbr
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0031-8693Childrens Robitussin Cough And Cold Long-acting also known as Chlorpheniramine Maleate, Dextrometrorphan Hbr is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Childrens Robitussin Cough And Cold Long-acting is 0031-8693. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Childrens Robitussin Cough And Cold Long-acting drug includes Chlorpheniramine Maleate - 2 mg/10mL Dextromethorphan Hydrobromide - 15 mg/10mL . The currest status of Childrens Robitussin Cough And Cold Long-acting drug is Active.
Drug Information:
| Drug NDC: | 0031-8693 |
| 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: | Childrens Robitussin Cough And Cold Long-acting |
| 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: | Chlorpheniramine Maleate, Dextrometrorphan Hbr |
| 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: | Liquid |
| 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: | CHLORPHENIRAMINE MALEATE - 2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE - 15 mg/10mL
|
| 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: | OTC MONOGRAPH FINAL |
| 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 Jan, 2004 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| 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: | part341 |
| 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: | 1111440
|
| 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: | V1Q0O9OJ9Z
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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
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 |
|---|
| 0031-8693-12 | 1 BOTTLE in 1 CARTON (0031-8693-12) / 118 mL in 1 BOTTLE | 01 Jan, 2004 | 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:
Purposes antihistamine cough suppressant
Product Elements:
Childrens robitussin cough and cold long-acting chlorpheniramine maleate, dextrometrorphan hbr chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan anhydrous citric acid fd&c red no. 40 glycerin lactic acid, unspecified form propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucralose red liquid
Indications and Usage:
Uses ⢠temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ⢠temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ⢠runny nose ⢠sneezing ⢠itchy, watery eyes ⢠itching of the nose or throat
Warnings:
Warnings do not use ⢠to sedate a child or to make a child sleepy ⢠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. ask a doctor before use if you have ⢠trouble urinating due to an enlarged prostate gland ⢠glaucoma ⢠a cough that occurs with too much phlegm (mucus) ⢠a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product ⢠do not use more than directed ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠be careful when dri
Read more...ving a motor vehicle or operating machinery ⢠excitability may occur, especially in children stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.
Do Not Use:
Warnings do not use ⢠to sedate a child or to make a child sleepy ⢠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. ask a doctor before use if you have ⢠trouble urinating due to an enlarged prostate gland ⢠glaucoma ⢠a cough that occurs with too much phlegm (mucus) ⢠a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product ⢠do not use more than directed ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.
When Using:
When using this product ⢠do not use more than directed ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠alcohol, sedatives, and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children
Dosage and Administration:
Directions ⢠measure only with dosing cup provided ⢠keep dosing cup with product ⢠ml = milliliter ⢠do not take more than 4 doses in any 24-hour period age dose children under 6 years do not use children 6 to under 12 years 10 ml every 6 hours adults and children 12 years and older 20 ml every 6 hours
Stop Use:
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel children's robitussin ages 6 & over nighttime cough dm long-acting chlorpheniramine maleate (antihistamine) dextromethorphan hbr (cough suppressant) relieves: ⢠cough up to 8 hours ⢠runny nose alcohol-free fruit punch flavor 4 fl oz (118 ml) paa172103 front carton robitussin nighttime cough dm 4 oz(118 ml)
Further Questions:
Questions or comments? call weekdays from 9 am to 5 pm est at 1-800-245-1040