Dayclear Allergy Relief Chewables
Chlophedianol Hydrochloride, Pyrilamine Maleate
Gm Pharmaceuticals, Inc
Human Otc Drug
NDC 58809-222Dayclear Allergy Relief Chewables also known as Chlophedianol Hydrochloride, Pyrilamine Maleate is a human otc drug labeled by 'Gm Pharmaceuticals, Inc'. National Drug Code (NDC) number for Dayclear Allergy Relief Chewables is 58809-222. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Dayclear Allergy Relief Chewables drug includes Chlophedianol Hydrochloride - 25 mg/1 Pyrilamine Maleate - 25 mg/1 . The currest status of Dayclear Allergy Relief Chewables drug is Active.
Drug Information:
| Drug NDC: | 58809-222 |
| 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: | Dayclear Allergy Relief Chewables |
| 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, Pyrilamine Maleate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Gm Pharmaceuticals, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Chewable |
| 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 - 25 mg/1
PYRILAMINE MALEATE - 25 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: | 02 Jan, 2020 |
| 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: | GM Pharmaceuticals, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2268215
|
| 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: | 69QQ58998Y
R35D29L3ZA
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 58809-222-24 | 1 BOTTLE in 1 CARTON (58809-222-24) / 24 TABLET, CHEWABLE in 1 BOTTLE | 02 Jan, 2020 | 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 antihistamine
Product Elements:
Dayclear allergy relief chewables chlophedianol hydrochloride, pyrilamine maleate crospovidone levomenthol magnesium stearate mannitol microcrystalline cellulose silicon dioxide stearic acid stevia rebaudiuna leaf sucralose chlophedianol hydrochloride chlophedianol pyrilamine maleate pyrilamine dc
Indications and Usage:
Uses â temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies: â itchy nose or throat â sneezing â itchy, watery eyes â runny nose â cough due to minor throat and bronchial irritation
Warnings:
Warnings ask a doctor before use if you have â a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema â glaucoma â difficulty in urination due to enlargement of the prostate gland â cough that occurs with too much phlegm (mucus) â a breathing problem such as emphysema or chronic bronchitis ask a doctor before use if you are taking sedative or tranquilizers when using this product â do not use more than directed â marked drowsiness may occur â avoid alcoholic drinks â alcohol, sedatives, and tranquilizers may increase drowsiness â be careful when driving a motor vehicle or operating machinery â excitability may occur, especially in children stop use and ask a doctor if â nervousness, dizziness, or sleeplessness occurs â symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. a persistent cough may be a sign of a serious condition â n
Read more...ew 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 â do not use more than directed â marked drowsiness may occur â avoid alcoholic drinks â alcohol, sedatives, and tranquilizers may increase drowsiness â be careful when driving a motor vehicle or operating machinery â excitability may occur, especially in children
Dosage and Administration:
Directions â do not exceed 4 doses per 24-hour period â adults and children 12 years and older: chew 1 tablet every 6 to 8 hours â children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if â nervousness, dizziness, or sleeplessness occurs â symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. a persistent cough may be a sign of a serious condition â new symptoms occur
Package Label Principal Display Panel:
Principal display panel ndc 58809-222-24 dayclear allergy relief chewables 24 chewable tablets principal display panel ndc 58809-222-24 dayclear allergy relief chewables 24 chewable tablets
Further Questions:
Questions or comments? call 1-888-535-0305 9 a.m. - 5 p.m. cst.