Primatene ®

Primatene ®
SPL v2
SPL
SPL Set ID 2170f081-c03f-47e8-bc63-4052c5e653fa
Route
ORAL
Published
Effective Date 2021-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ephedrine (12.5 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Imprint: PT;in;circle;engraved Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-22

Description

Drug Facts

Purpose

Bronchodilator


Medication Information

Purpose

Bronchodilator

Description

Drug Facts

Use
  • for temporary relief of mild symptoms of intermittent asthma:
    • wheezing
    • tightness of chest
    • shortness of breath
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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
Section 50567-7

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
Section 50568-5

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)
Section 50569-3

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
Section 50570-1

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
Section 53414-9

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

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

Active Ingredient (in Each Tablet)

Ephedrine HCl 12.5 mg

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


Structured Label Content

Use
  • for temporary relief of mild symptoms of intermittent asthma:
    • wheezing
    • tightness of chest
    • shortness of breath
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

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)
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 53414-9 (53414-9)

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

Purpose

Bronchodilator

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
Asthma Alert (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.
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 Or Comments? (Questions or comments?)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Ephedrine HCl 12.5 mg

Principal Display Panel 12.5 Mg Tablet Blister Pack Carton (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)