Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride
Westminster Pharmaceuticals, Llc
Human Otc Drug
NDC 69367-183Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride is a human otc drug labeled by 'Westminster Pharmaceuticals, Llc'. National Drug Code (NDC) number for Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride is 69367-183. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride drug includes Chlophedianol Hydrochloride - 12.5 mg/5mL Dexchlorpheniramine Maleate - 1 mg/5mL Pseudoephedrine Hydrochloride - 30 mg/5mL . The currest status of Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 69367-183 |
| 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: | Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride |
| 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: | Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Westminster Pharmaceuticals, 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: | CHLOPHEDIANOL HYDROCHLORIDE - 12.5 mg/5mL
DEXCHLORPHENIRAMINE MALEATE - 1 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE - 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: | 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: | 29 Jul, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | 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: | Westminster Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1369424
|
| 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: | 0369367183161
|
| UPC stands for Universal Product Code. |
| UNII: | 69QQ58998Y
B10YD955QW
6V9V2RYJ8N
|
| 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 alpha-Agonists [MoA]
alpha-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 |
|---|
| 69367-183-16 | 473 mL in 1 BOTTLE (69367-183-16) | 29 Jul, 2021 | 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 chlophedianol hydrochloride 12.5 mg cough suppressant dexchlorpheniramine maleate 1 mg antihistamine pseudoephedrine hydrochloride 30 mg nasal decongestant
Product Elements:
Chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride chlophedianol hydrochloride chlophedianol dexchlorpheniramine maleate dexchlorpheniramine pseudoephedrine hydrochloride pseudoephedrine anhydrous citric acid glycerin propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucralose
Indications and Usage:
Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces congestion reduces swelling of nasal passages
Warnings:
Warnings do not exeed recommended dosage. do not use this product 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 a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease high blood pressure thyroid disease diabetes ask a doctor before use if you are taking sedatives or tranquilizers. when using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness
Read more...effect use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, diziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. a persistent cough may be a sign of a serious condition. new symptoms occur 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 exeed recommended dosage. do not use this product 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 a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease high blood pressure thyroid disease diabetes ask a doctor before use if you are taking sedatives or tranquilizers. when using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, diziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. a persistent cough may be a sign of a serious condition. new symptoms occur 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 may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not exceed recommended dosage. adults and children 12 years of age and over: 2 teaspoonfuls every 6 hours, not to exeed 8 teaspoonfuls in 24 hours. children 6 to under 12 years of age: 1 teaspoonful every 6 hours, not to exeed 4 teaspoonfuls in 24 hours. children under 6 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if nervousness, diziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. a persistent cough may be a sign of a serious condition. new symptoms occur
Package Label Principal Display Panel:
Principal display panel - 473 ml bottle label ndc 69367-183-16 chlophedianol hcl, dexchlorpheniramine maleate and pseudoephedrine hcl cough suppressant antihistamine nasal decongestant sugar free, alcohol free, dye free tutti frutti flavor each 5 ml (1 teaspoonful) contains: chlophedianol hydrochloride 12.5 mg dexchlorpheniramine maleate 1 mg pseudoephedrine hydrochloride 30 mg 16 fl. oz. (473 ml) westminster pharmaceuticals principal display panel - 473 ml bottle label
Further Questions:
Questions or comments? call weekdays from 9 am to 5 pm est at 1-844-7294. you may also report serious side effects to this phone number.