Ephed Asthma

Dosage form: tablet
Ingredients: EPHEDRINE HYDROCHLORIDE 25mg, GUAIFENESIN 200mg
Labeler: Dickey Consumer Products DBA DMD
NDC Code: 65193-320

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

Purpose- Bronchodilator, Expectorant

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.

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

If preganant or breast feeding a baby, con\sult a doctor before use

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

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

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.

MM1



EPHED ASTHMA 
ephedrine hydrochloride, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65193-320
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE HYDROCHLORIDE (EPHEDRINE) EPHEDRINE HYDROCHLORIDE25 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MALTODEXTRIN 
Product Characteristics
Colorwhite (snow white) Score4 pieces
ShapeROUND (EP225) Size9mm
FlavorImprint CodeEP225
Contains    
Packaging
#Item CodePackage Description
1NDC:65193-320-2424 TABLET (TABLET) in 1 BLISTER PACK
2NDC:65193-320-196 TABLET (TABLET) in 1 BLISTER PACK
3NDC:65193-320-462 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/13/2011
Labeler - Dickey Consumer Products DBA DMD (835974056)
Registrant - Dickey Consumer Products DBA DMD (835974056)
Establishment
NameAddressID/FEIOperations
Ultratab Laboratories, Inc.151051757manufacture

Revised: 12/2011
 
Dickey Consumer Products DBA DMD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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