Bronchial Asthma Relief
Ephedrine Hcl, Guaifenesin
Walgreen Company
Human Otc Drug
NDC 0363-2529Bronchial Asthma Relief also known as Ephedrine Hcl, Guaifenesin is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Bronchial Asthma Relief is 0363-2529. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Bronchial Asthma Relief drug includes Ephedrine Hydrochloride - 12.5 mg/1 Guaifenesin - 200 mg/1 . The currest status of Bronchial Asthma Relief drug is Active.
Drug Information:
| Drug NDC: | 0363-2529 |
| 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: | Bronchial Asthma Relief |
| 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: | Ephedrine Hcl, Guaifenesin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreen Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | EPHEDRINE HYDROCHLORIDE - 12.5 mg/1
GUAIFENESIN - 200 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: | 13 Feb, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 Apr, 2023 |
| 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: | 06 May, 2026 |
| 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: | Walgreen Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1115991
|
| 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. |
| NUI: | N0000193956
N0000008867
N0000009560
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | NLJ6390P1Z
495W7451VQ
|
| 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 EPC: | Expectorant [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Respiratory Secretion Viscosity [PE]
Increased Respiratory Secretions [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Adrenergic alpha-Agonists [MoA]
Adrenergic beta-Agonists [MoA]
Decreased Respiratory Secretion Viscosity [PE]
Expectorant [EPC]
Increased Norepinephrine Activity [PE]
Increased Respiratory Secretions [PE]
Norepinephrine Releasing Agent [EPC]
alpha-Adrenergic Agonist [EPC]
beta-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 |
|---|
| 0363-2529-67 | 4 BLISTER PACK in 1 CARTON (0363-2529-67) / 15 TABLET in 1 BLISTER PACK | 13 Feb, 2002 | 30 Apr, 2023 | 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 bronchodilator expectorant
Product Elements:
Bronchial asthma relief ephedrine hcl, guaifenesin crospovidone d&c yellow no. 10 magnesium stearate maltodextrin cellulose, microcrystalline povidone k30 silicon dioxide stearic acid guaifenesin guaifenesin ephedrine hydrochloride ephedrine cpc;2529
Indications and Usage:
Uses for temporarily relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and make coughs more productive
Warnings:
Warnings asthma alert: because asthma may be life threatening, see a doctor if you are not better in 60 minutes get worse need 12 tablets in any day use more than 8 tablets a day for more than 3 days a week have more than 2 asthma attacks in a week these may be signs that your asthma is getting worse this product will not give you asthma relief as quickly as an inhaled bronchodilator do not use unless a doctor said you have asthma if you are now taking prescription monoamine oxidase inhibitor (maoi) (certain drugs taken for depression, psychiatric or emotional conditions, or parkinsonâs 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 doctor before use if you have: ever been hospitalized for asthma heart disease high blood pressure diabetes thyroid disease seizures narrow angle glaucoma a psychiatric or emotional condition trouble urinating due to enlarge
Read more...ment of the prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema ask doctor/pharmacist before use if you are taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain) stop use and ask a doctor if your asthma is getting worse (see asthma alert) you have difficulty sleeping you have rapid heartbeat you have tremors, nervousness, or seizure 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. when using this product your blood pressure or heart rate may go up. this could increase your risk of heart attack or stroke, which may cause death. your risk of heart attack or stroke increases if you: have a history of high blood pressure or heart disease take this product more frequently or take more than the recommended dose avoid foods or beverages that contain caffeine avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect pregnancy or breast feeding ask a health professional before use. keep out of reach of children in case of overdose, get medical help or contact poison control center right away.
Do Not Use:
Warnings asthma alert: because asthma may be life threatening, see a doctor if you are not better in 60 minutes get worse need 12 tablets in any day use more than 8 tablets a day for more than 3 days a week have more than 2 asthma attacks in a week these may be signs that your asthma is getting worse this product will not give you asthma relief as quickly as an inhaled bronchodilator do not use unless a doctor said you have asthma if you are now taking prescription monoamine oxidase inhibitor (maoi) (certain drugs taken for depression, psychiatric or emotional conditions, or parkinsonâs 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 doctor before use if you have: ever been hospitalized for asthma heart disease high blood pressure diabetes thyroid disease seizures narrow angle glaucoma a psychiatric or emotional condition trouble urinating due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema ask doctor/pharmacist before use if you are taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain) stop use and ask a doctor if your asthma is getting worse (see asthma alert) you have difficulty sleeping you have rapid heartbeat you have tremors, nervousness, or seizure 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. when using this product your blood pressure or heart rate may go up. this could increase your risk of heart attack or stroke, which may cause death. your risk of heart attack or stroke increases if you: have a history of high blood pressure or heart disease take this product more frequently or take more than the recommended dose avoid foods or beverages that contain caffeine avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect pregnancy or breast feeding ask a health professional before use. keep out of reach of children in case of overdose, get medical help or contact poison control center right away.
When Using:
When using this product your blood pressure or heart rate may go up. this could increase your risk of heart attack or stroke, which may cause death. your risk of heart attack or stroke increases if you: have a history of high blood pressure or heart disease take this product more frequently or take more than the recommended dose avoid foods or beverages that contain caffeine avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect
Dosage and Administration:
Dosage and administration do not exceed dosage this adult product is not intended for use in children under 12 years of age adults and children 12 years of age and over take 1-2 tablets every 4 hours as needed, not to exceed 12 tablets in 24 hours children under 12 years of age ask a doctor
Stop Use:
Stop use and ask a doctor if your asthma is getting worse (see asthma alert) you have difficulty sleeping you have rapid heartbeat you have tremors, nervousness, or seizure 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:
Package label.principal display panel walgreens bronchial asthma relief ephedrine hcl, usp 12.5 mg/ bronchodilator guaifenesin, usp 200 mg/ expectorant helps breathing without drowsiness restores free breathing loosens phlegm compare to primatene® active ingredients# maximum sale: one package per customer not for sale to minors walgreen label
Further Questions:
Questions or comments? call 1-800-925-4733