Primatene
Ephedrine Hydrochloride
Foundation Consumer Brands
Human Otc Drug
NDC 80070-600Primatene also known as Ephedrine Hydrochloride is a human otc drug labeled by 'Foundation Consumer Brands'. National Drug Code (NDC) number for Primatene is 80070-600. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Primatene drug includes Ephedrine Hydrochloride - 12.5 mg/1 . The currest status of Primatene drug is Active.
Drug Information:
| Drug NDC: | 80070-600 |
| 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: | Primatene |
| 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 Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Foundation Consumer Brands |
| 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
|
| 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: | 22 Jan, 2021 |
| 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: | Foundation Consumer Brands
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2534871
2591390
|
| 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: | NLJ6390P1Z
|
| 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]
Adrenergic beta-Agonists [MoA]
Increased Norepinephrine Activity [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 |
|---|
| 80070-600-24 | 2 BLISTER PACK in 1 CARTON (80070-600-24) / 12 TABLET in 1 BLISTER PACK | 22 Jan, 2021 | N/A | No |
| 80070-600-60 | 5 BLISTER PACK in 1 CARTON (80070-600-60) / 12 TABLET in 1 BLISTER PACK | 22 Jan, 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:
Purpose bronchodilator
Product Elements:
Primatene ephedrine hydrochloride ephedrine hydrochloride ephedrine silicon dioxide dibasic calcium phosphate dihydrate d&c yellow no. 10 aluminum lake fd&c yellow no. 6 magnesium stearate microcrystalline cellulose sodium starch glycolate type a potato stearic acid light yellow color pt;in;circle;engraved
Indications and Usage:
Use for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath
Warnings:
Warnings asthma alert because asthma may be life threatening, see a doctor if you are not better in 60 minutes get worse need more than 12 tablets in 24 hours use more than 8 tablets in 24 hours for 3 or more 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 a prescription monoamine oxidase inhibitor (maoi) (certain drugs taken 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have ever been hospitalized for asthma heart disease high blood pressure diabetes thyroid disease se
Read more...izures narrow angle glaucoma a psychiatric or emotional condition trouble urinating due to an enlarged prostate gland ask a doctor or 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) 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 stop use and ask a doctor if your asthma is getting worse (see asthma alert ) you have difficulty sleeping you have a rapid heart beat you have tremors, nervousness, or seizure 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 asthma alert because asthma may be life threatening, see a doctor if you are not better in 60 minutes get worse need more than 12 tablets in 24 hours use more than 8 tablets in 24 hours for 3 or more 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 a prescription monoamine oxidase inhibitor (maoi) (certain drugs taken 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a 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 an enlarged prostate gland ask a doctor or 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) 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 stop use and ask a doctor if your asthma is getting worse (see asthma alert ) you have difficulty sleeping you have a rapid heart beat you have tremors, nervousness, or seizure 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 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:
Directions do not take more than directed adults and children 12 years and over: take 1-2 tablets every 4 hours as needed. do not take more than 12 tablets in 24 hours. children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if your asthma is getting worse (see asthma alert ) you have difficulty sleeping you have a rapid heart beat you have tremors, nervousness, or seizure
Package Label Principal Display Panel:
Principal display panel - 12.5 mg tablet blister pack carton new formula primatene ® tablets ephedrine hcl 12.5 mg bronchodilator for the temporary relief of mild symptoms of intermittent asthma 24 tablets principal display panel - 12.5 mg tablet blister pack carton
Further Questions:
Questions or comments? call 1-800-535-0026 weekdays 9 am to 5 pm est