FDA Label for Ephed Asthma
View Indications, Usage & Precautions
Ephed Asthma Product Label
The following document was submitted to the FDA by the labeler of this product Dickey Consumer Products Dba Dmd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg
Otc - Purpose
Purpose- Bronchodilator, Expectorant
Warnings
Asthma Alert: because asthma may be life threatening, see a doctor if you:Are not better in 60 minutes,g 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 telief as quickly as an inhaled bronchodilator
Do not exceed recommended dosage. If dizziness or sleeplessness occur, consult a doctor.
Do not use: Unless a doctor has said that 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 are
uncertain whether your prescription drug contains an MAOI, consult a
health professional before using 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 anlargement of the 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 if you are: Taking prescription drugs for asthma, weight control, obesity, or depression, or psychiatric or emotional conditions. Taking drugs that contain 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, or 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. Intentional abuse of this product can be harmful or fatal.
Stop use and ask a doctor if your asthma is getting worse, you have difficulty sleeping, you have a rapid heart beat. You have tremors nervousness or seizure.Cough lasts more than 7 days or comes back , or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - 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 immediately.
Otc - Pregnancy Or Breast Feeding
If preganant or breast feeding a baby, con\sult a doctor before use
Inactive Ingredient
Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate,Stearic Acid
Dosage & Administration
Adults and children 12 years of age and older: 1 tablet every 4 hours as needed. Do not take more than 6 tablets in 24 hours. Children under 12 years of age: Ask a doctor
Indications & Usage
For the 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.
Package Label.Principal Display Panel
MM1
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