Cough And Cold
Chlorpheniramine Maleate, Dextromethorphan Hbr
Major Pharmaceuticals
Human Otc Drug
NDC 0904-6634Cough And Cold also known as Chlorpheniramine Maleate, Dextromethorphan Hbr is a human otc drug labeled by 'Major Pharmaceuticals'. National Drug Code (NDC) number for Cough And Cold is 0904-6634. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Cough And Cold drug includes Chlorpheniramine Maleate - 4 mg/1 Dextromethorphan Hydrobromide - 30 mg/1 . The currest status of Cough And Cold drug is Active.
Drug Information:
| Drug NDC: | 0904-6634 |
| 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: | Cough And Cold |
| 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, Dextromethorphan Hbr |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Major Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| 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 - 4 mg/1
DEXTROMETHORPHAN HYDROBROMIDE - 30 mg/1
|
| 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: | 31 Mar, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | 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, 2023 |
| 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: | Major Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1421985
|
| 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. |
| UPC: | 0309046634447
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 0904-6634-44 | 2 BLISTER PACK in 1 CARTON (0904-6634-44) / 8 TABLET, COATED in 1 BLISTER PACK | 31 Mar, 2017 | 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 antihistamine cough suppressant
Product Elements:
Cough and cold chlorpheniramine maleate, dextromethorphan hbr chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan croscarmellose sodium d&c red no. 27 aluminum lake fd&c yellow no. 6 anhydrous lactose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide stearic acid talc titanium dioxide 44;689
Indications and Usage:
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves runny nose and sneezing due to the common cold
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. ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland cough that occurs with excessive phlegm (mucus) glaucoma a breathing problem or persistent or chronic cough 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 excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if persistent cou
Read more...gh lasts for more than one week, tends to recur, 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 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 difficulty in urination due to enlargement of the prostate gland cough that occurs with excessive phlegm (mucus) glaucoma a breathing problem or persistent or chronic cough 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 excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if persistent cough lasts for more than one week, tends to recur, 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 excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not exceed recommended dose adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours. children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if persistent cough lasts for more than one week, tends to recur, 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 major® ndc 0904-6634-44 compare to the active ingredients in coricidin® hbp cough & cold* cough & cold hbp chlorpheniramine maleate dextromethorphan hbr antihistamine/ cough suppressant relieves: cough, runny nose, sneezing for people with high blood pressure decongestant free 16 tablets actual size tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering *this product is not manufactured or distributed by bayer healthcare llc, owner of the registered trademark coricidin® hbp cough & cold. 50844 rev0121a68921 distributed by: major® pharmaceuticals livonia, mi 48152 parents: learn about teen medicine abuse www.stopmedicineabuse.org major 44-689 major 44-689
Further Questions:
Questions or comments? (800) 616-2471