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Generic: ephedrine hydrochloride is used for the treatment of Arrhythmias, Cardiac Asthma Bronchial Spasm Hypotension, Orthostatic Rhinitis Glaucoma, Angle-Closure


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Drug Facts

Active Ingredient (in Each Tablet)


Ephedrine HCl 12.5 mg

Purpose


Bronchodilator

Use

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

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 weekThese may be signs that your asthma is getting worse.
  • This product will not give you asthma relief as quickly as an inhaled bronchodilator.

OTC - DO NOT USE SECTION


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

OTC - ASK DOCTOR SECTION


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

OTC - ASK DOCTOR/PHARMACIST SECTION


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)

OTC - WHEN USING SECTION


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

OTC - STOP USE SECTION


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

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

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

  • store at 20-25°C (68-77°F)

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 Or Comments?


Call 1-800-535-0026 weekdays 9 AM to 5 PM EST


Distributed by:Foundation Consumer Brands, LLCPittsburgh, PA 15212

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

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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