Primatene

Ephedrine Hydrochloride · Tablet · Oral

Over the counter Norepinephrine Releasing Agent alpha-Adrenergic Agonist beta-Adrenergic Agonist

Active ingredient

Active ingredient (in each tablet) Ephedrine HCl 12.5 mg

Purpose

Purpose Bronchodilator

Uses

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 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.

Do not use

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

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

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

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

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

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

Other information store at 20-25°C (68-77°F)

Inactive ingredients

Inactive ingredients D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, stearic acid

Questions?

Questions or comments? Call 1-800-535-0026 weekdays 9 AM to 5 PM EST

Label text from the FDA structured product label by Foundation Consumer Brands (revised Nov 7, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Primatene NDC products (1)

NDCStrength & formLabelerType
80070-600Ephedrine Hydrochloride 12.5 mg/1
Tablet
Foundation Consumer BrandsOTC MONOGRAPH DRUG

Frequently asked questions

What is Primatene used for?

Use for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath

Who makes Primatene?

Primatene is listed by 1 labeler in the FDA NDC directory, including Foundation Consumer Brands.