Dometuss
Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Domel Laboratories
Human Otc Drug
NDC 53809-202Dometuss also known as Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride is a human otc drug labeled by 'Domel Laboratories'. National Drug Code (NDC) number for Dometuss is 53809-202. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Dometuss drug includes Chlorpheniramine Maleate - 4 mg/5mL Dextromethorphan Hydrobromide - 20 mg/5mL Phenylephrine Hydrochloride - 10 mg/5mL . The currest status of Dometuss drug is Active.
Drug Information:
| Drug NDC: | 53809-202 |
| 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: | Dometuss |
| 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 Hydrobromide, And Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Domel Laboratories |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Syrup |
| 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/5mL
DEXTROMETHORPHAN HYDROBROMIDE - 20 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE - 10 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: | 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 Aug, 2015 |
| 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, 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: | Domel Laboratories
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1489310
|
| 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
04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
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]
alpha-1 Adrenergic Agonist [EPC]
|
| 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 |
|---|
| 53809-202-04 | 118 mL in 1 BOTTLE (53809-202-04) | 01 Aug, 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:
Active ingredients (in each 5 ml-teaspoonful) purpose chlorpheniramine maleate 4 mg antihistamine dextromethorphan hbr 20 mg cough suppressant phenylephrine hcl 10 mg nasal decongestant
Product Elements:
Dometuss chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine citric acid monohydrate glycerin hydroxyethyl cellulose (2000 mpa.s at 1%) methylparaben propylene glycol propylparaben water sodium citrate, unspecified form sucralose
Indications and Usage:
Use for temporary relief of runny nose, sneezing,itching of the nose or throat and itchy watery eyes due to hay fever. temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. temporarily restores freer breathing through the nose
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 heart disease thyroid disease trouble urinating due to enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problems or chronic cough that lasts such 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 exceed recommended dosage may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause increased drowsiness be careful when driving a motor vehicle or operating mach
Read more...inery excitability may occur, especially with children. stop use and ask a doctor if you get nervous, dizzy, or sleepless. cough last more than 7 day, comes back, or is accompanied by fever, rash or persistent headaches. 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 accidental 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 heart disease thyroid disease trouble urinating due to enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problems or chronic cough that lasts such 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 exceed recommended dosage may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause increased drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially with children. stop use and ask a doctor if you get nervous, dizzy, or sleepless. cough last more than 7 day, comes back, or is accompanied by fever, rash or persistent headaches. 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 accidental overdose, get medical help or contact a poison control center right away.
When Using:
When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause increased drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially with children.
Dosage and Administration:
Directions do not exceed more than 6 doses in any 24-hour period adults and children 12 years of age and over take 1 teaspoonful (5 ml) every 4 hours children 6 to under 12 years of age take 1/2 teaspoonful (2.5 ml) every 4 hours children under 6 years of age ask a doctor
Stop Use:
Stop use and ask a doctor if you get nervous, dizzy, or sleepless. cough last more than 7 day, comes back, or is accompanied by fever, rash or persistent headaches. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel - 118 ml bottle label ndc 53809-202-04 dometuss antihistamine/cough suppressant /nasal decongestant sugar, alcohol, and dye free grape flavor 4 fl. oz (118 ml) principal display panel - 118 ml bottle label
Further Questions:
Questions or comments? please call (787) 767-3246