FDA Label for Primatene

Other

Drug Facts

Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

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
  
  

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.

Otc - 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

Otc - Ask Doctor

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

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

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

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

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

Otc - 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

• 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

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 - primatene 01