PRIMATENE ephedrine HCl, guaifenesin EPHEDRINE HYDROCHLORIDE EPHEDRINE GUAIFENESIN GUAIFENESIN SILICON DIOXIDE CROSPOVIDONE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED Light yellow color P;in;circle;engraved;bisect
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL NDC 0573-2952-20 Primatene ® TABLETS Ephedrine HCl, Bronchodilator/Guaifenesin, Expectorant Helps Loosen Phlegm (Mucus) For the Temporary Relief of Mild Symptoms of INTERMITTENT ASTHMA 60 TABLETS Principal Display Panel - 60 Tablet Carton
- PRINCIPAL DISPLAY PANEL NDC 0573-2952-20 Primatene ® TABLETS Ephedrine HCl, Bronchodilator/Guaifenesin, Expectorant Helps Loosen Phlegm (Mucus) For the Temporary Relief of Mild Symptoms of INTERMITTENT ASTHMA 60 TABLETS Principal Display Panel - 60 Tablet Carton
Overview
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
Indications & Usage
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
Dosage & Administration
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
Warnings & Precautions
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 (see Asthma 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 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.
Purpose
PURPOSES Bronchodilator Expectorant
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.
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
Stop Use & 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 • 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.
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.
Storage & Handling
OTHER INFORMATION • store at 20-25°C (68-77°F)
Questions
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
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