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 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

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

Mfr: OTC
FunFoxMeds box

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENTS (IN EACH TABLET) Ephedrine HCl USP 12.5 mg Guaifenesin USP 200 mg
Inactive Ingredients
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
Strengths
12.5 mg 200 mg
Quantities
60 tablets 60 tablet
Treats Conditions
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

Identifiers & Packaging

Container Type BOX
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

Package Descriptions
  • 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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