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PRIMATENE (ephedrine hydrochloride 12.5 mg guaifenesin 200 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Generic: ephedrine hcl, guaifenesin

PRIMATENE tablet - (ephedrine hydrochloride 12.5 mg guaifenesin 200 mg) image
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IMPRINT: P     SHAPE: round
    COLOR: yellow

All Imprints

primatene (ephedrine hcl, guaifenesin) tablet - p round yellow

  1. FDA Adverse Reactions

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Active Ingredients (in Each Tablet)


Ephedrine HCl, USP 12.5 mg

Guaifenesin, USP 200 mg

Purposes


Bronchodilator

Expectorant

Uses

  • •for temporary relief of mild symptoms of intermittent asthma:
    • •wheezing
    • •tightness of chest
    • •shortness of breath
  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive

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.

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
  • •cough that occurs with too much phlegm (mucus)
  • •cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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)

Stop use and ask a doctor if

  • •your asthma is getting worse (seeAsthma alert)
  • •you have difficulty sleeping
  • •you have a rapid heart beat
  • •you have tremors, nervousness, or seizure
  • •cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 - 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
age dose

adults and children 12 years of age and over
oral dose is 1-2 tablets (12.5 to 25 mg) every 4 hours as needed. Do not take more than 12 tablets (150 mg) in 24 hours

children under 12 years of age
ask a doctor

Other Information

  • •store at 20-25°C (68-77°F)

Inactive Ingredients


colloidal silicon dioxide, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone

Questions Or Comments?


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

For most recent product information, visit www.PrimateneTablets.com

Principal Display Panel


NDC 0573-2952-20

Primatene® TABLETS

Ephedrine HCl, Bronchodilator/Guaifenesin, ExpectorantHelps Loosen Phlegm (Mucus)

For the Temporary Relief of Mild Symptoms of INTERMITTENT ASTHMA

60 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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