Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 172e970d-6773-4796-a280-3370e2f46c69
Route
ORAL
Published
Effective Date 2019-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ephedrine (25 mg) Guaifenesin (200 mg)
Inactive Ingredients
Povidone K30 Stearic Acid Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato Maltodextrin

Identifiers & Packaging

Pill Appearance
Imprint: EP225 Shape: round Color: white Size: 9 mm Score: 4
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-13

Description

Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg


Medication Information

Warnings and Precautions

Asthma Alert:  because asthma may be life threatening, see a doctor if you: • Are not better in 60 minutes • get worse • need more than 6 tablets in 24 hours • use more than 4 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 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 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)



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 food or beverages that contain caffeine • Avoid dietary supplements containing ingredients reported or claim to have a stimulant effect.  



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 seizures • cough lasts more than 1 week, comes back , or occurs with fever, rash, or persistent headache.  These could be signs of a serious condition.

Indications and Usage

• 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 and Administration

• do not take more than directed • adults and children 12 years of age and over: 1 tablet every 4 hours as needed, do not take more than 6 tablets in 24 hours • children under 12 years of age: do not use

Description

Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg

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 51727-6

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate,Stearic Acid

Section 51945-4

Section 53414-9

If pregnant or breast feeding, ask a health proffessional before use

Section 55105-1

Purposes - Bronchodilator, Expectorant

Section 55106-9

Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg


Structured Label Content

Indications and Usage (34067-9)

• 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 and Administration (34068-7)

• do not take more than directed • adults and children 12 years of age and over: 1 tablet every 4 hours as needed, do not take more than 6 tablets in 24 hours • children under 12 years of age: do not use

Warnings and Precautions (34071-1)

Asthma Alert:  because asthma may be life threatening, see a doctor if you: • Are not better in 60 minutes • get worse • need more than 6 tablets in 24 hours • use more than 4 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 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 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)



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 food or beverages that contain caffeine • Avoid dietary supplements containing ingredients reported or claim to have a stimulant effect.  



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 seizures • cough lasts more than 1 week, comes back , or occurs with fever, rash, or persistent headache.  These could be signs of a serious condition.

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 51727-6 (51727-6)

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate,Stearic Acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health proffessional before use

Section 55105-1 (55105-1)

Purposes - Bronchodilator, Expectorant

Section 55106-9 (55106-9)

Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg


Advanced Ingredient Data


Raw Label Data

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