DOSAGE & ADMINISTRATION SECTION.


DIRECTIONS. odo not take more than directedagedoseadults and children 12 years of age and overoral dose is 1-2 tablets (12.5 to 25 mg) every hours as needed. Do not take more than 12 tablets (150 mg) in 24 hourschildren under 12 years of ageask doctor. odo not take more than directed.

INACTIVE INGREDIENT SECTION.


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

INDICATIONS & USAGE SECTION.


USES. ofor temporary relief of mild symptoms of intermittent asthma:owheezingotightness of chestoshortness of breathohelps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive. ofor temporary relief of mild symptoms of intermittent asthma:owheezingotightness of chestoshortness of breath. owheezing. otightness of chest. oshortness of breath. ohelps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive.

OTC - ACTIVE INGREDIENT SECTION.


ACTIVE INGREDIENTS (IN EACH TABLET). Ephedrine HCl, USP 12.5 mgGuaifenesin, USP 200 mg.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have. oever been hospitalized for asthmaoheart diseaseohigh blood pressureodiabetesothyroid diseaseoseizuresonarrow angle glaucomaoa psychiatric or emotional conditionotrouble urinating due to an enlarged prostate glandocough that occurs with too much phlegm (mucus)ocough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. oever been hospitalized for asthma. oheart disease. ohigh blood pressure. odiabetes. othyroid disease. oseizures. onarrow angle glaucoma. oa psychiatric or emotional condition. otrouble urinating due to an enlarged prostate gland. ocough that occurs with too much phlegm (mucus). ocough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are. otaking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditionsotaking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain). otaking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions. otaking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).

OTC - DO NOT USE SECTION.


Do not use. ounless doctor said you have asthmaoif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.. ounless doctor said you have asthma. oif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


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

OTC - PREGNANCY OR BREAST FEEDING SECTION.


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

OTC - PURPOSE SECTION.


PURPOSES. BronchodilatorExpectorant.

OTC - QUESTIONS SECTION.


QUESTIONS OR COMMENTS. Call weekdays from AM to PM EST at 1-800-535-0026 For most recent product information, visit www.PrimateneTablets.com.

OTC - STOP USE SECTION.


Stop use and ask doctor if. oyour asthma is getting worse (see Asthma alert)oyou have difficulty sleepingoyou have rapid heart beatoyou have tremors, nervousness, or seizureocough lasts more than days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious condition.. oyour asthma is getting worse (see Asthma alert). oyou have difficulty sleeping. oyou have rapid heart beat. oyou have tremors, nervousness, or seizure. ocough lasts more than days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious condition.

OTC - WHEN USING SECTION.


When using this product. oyour blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.oyour risk of heart attack or stroke increases if you:ohave history of high blood pressure or heart diseaseotake this product more frequently or take more than the recommended doseoavoid foods or beverages that contain caffeineoavoid dietary supplements containing ingredients reported or claimed to have stimulant effect. oyour blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.. oyour risk of heart attack or stroke increases if you:ohave history of high blood pressure or heart diseaseotake this product more frequently or take more than the recommended dose. ohave history of high blood pressure or heart disease. otake this product more frequently or take more than the recommended dose. oavoid foods or beverages that contain caffeine. oavoid dietary supplements containing ingredients reported or claimed to have stimulant effect.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL. NDC 0573-2952-20Primatene(R) TABLETSEphedrine HCl, Bronchodilator/Guaifenesin, ExpectorantHelps Loosen Phlegm (Mucus)For the Temporary Relief of Mild Symptoms ofINTERMITTENT ASTHMA60 TABLETS. Principal Display Panel 60 Tablet Carton.

SPL UNCLASSIFIED SECTION.


Asthma alert. Because asthma may be life threatening, see doctor if youoare not better in 60 minutesoget worseoneed more than 12 tablets in 24 hoursouse more than tablets in 24 hours for or more days weekohave more than asthma attacks in weekThese may be signs that your asthma is getting worseoThis product will not give you asthma relief as quickly as an inhaled bronchodilator. oare not better in 60 minutes. oget worse. oneed more than 12 tablets in 24 hours. ouse more than tablets in 24 hours for or more days week. ohave more than asthma attacks in week. oThis product will not give you asthma relief as quickly as an inhaled bronchodilator.

STORAGE AND HANDLING SECTION.


OTHER INFORMATION. ostore at 20-25C (68-77F). ostore at 20-25C (68-77F).

WARNINGS SECTION.


WARNINGS. Asthma alert. Because asthma may be life threatening, see doctor if youoare not better in 60 minutesoget worseoneed more than 12 tablets in 24 hoursouse more than tablets in 24 hours for or more days weekohave more than asthma attacks in weekThese may be signs that your asthma is getting worseoThis product will not give you asthma relief as quickly as an inhaled bronchodilator. oare not better in 60 minutes. oget worse. oneed more than 12 tablets in 24 hours. ouse more than tablets in 24 hours for or more days week. ohave more than asthma attacks in week. oThis product will not give you asthma relief as quickly as an inhaled bronchodilator. Do not use. ounless doctor said you have asthmaoif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.. ounless doctor said you have asthma. oif you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.. Ask doctor before use if you have. oever been hospitalized for asthmaoheart diseaseohigh blood pressureodiabetesothyroid diseaseoseizuresonarrow angle glaucomaoa psychiatric or emotional conditionotrouble urinating due to an enlarged prostate glandocough that occurs with too much phlegm (mucus)ocough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. oever been hospitalized for asthma. oheart disease. ohigh blood pressure. odiabetes. othyroid disease. oseizures. onarrow angle glaucoma. oa psychiatric or emotional condition. otrouble urinating due to an enlarged prostate gland. ocough that occurs with too much phlegm (mucus). ocough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. Ask doctor or pharmacist before use if you are. otaking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditionsotaking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain). otaking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions. otaking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain). Stop use and ask doctor if. oyour asthma is getting worse (see Asthma alert)oyou have difficulty sleepingoyou have rapid heart beatoyou have tremors, nervousness, or seizureocough lasts more than days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious condition.. oyour asthma is getting worse (see Asthma alert). oyou have difficulty sleeping. oyou have rapid heart beat. oyou have tremors, nervousness, or seizure. ocough lasts more than days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious condition.. When using this product. oyour blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.oyour risk of heart attack or stroke increases if you:ohave history of high blood pressure or heart diseaseotake this product more frequently or take more than the recommended doseoavoid foods or beverages that contain caffeineoavoid dietary supplements containing ingredients reported or claimed to have stimulant effect. oyour blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.. oyour risk of heart attack or stroke increases if you:ohave history of high blood pressure or heart diseaseotake this product more frequently or take more than the recommended dose. ohave history of high blood pressure or heart disease. otake this product more frequently or take more than the recommended dose. oavoid foods or beverages that contain caffeine. oavoid dietary supplements containing ingredients reported or claimed to have stimulant effect. If pregnant or breast-feeding, ask health professional before use.. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.