FDA Label for Refenesen Mucus Relief DM

View Indications, Usage & Precautions

Refenesen Mucus Relief DM Product Label

The following document was submitted to the FDA by the labeler of this product Reese Pharmaceutical Co. 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.

Active Ingredients - (Per Tablet)



Dextromethorphan Hydrobromide   20mg
Guaifenesin  400mg


Purpose



Cough Suppressant

Expectorant


Uses



■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■ Helps make coughs more productive.


Warnings



Do not use  ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.


Ask Doctor Before Use If You Have



■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
■ cough is accompanied by excessive phlegm (mucus)


Stop Use And Ask Doctor If



■ symptoms are accompanied by fever, rash or persistent headache

■ cough persists for more than 1 week or tends to recur.

A persistent cough may be a sign of a serious condition.


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 Center immediately.


Directions



Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
Children under 6 years of age: consult a doctor.   
Do not exceed 6 doses in a 24 hour period or as directed by a doctor


Other Information



Store at 15°-30°C (59°-86°F)


Inactive Ingredients



Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin, Stearic acid, Povidone K30, Povidone 90F


Package Label.Principal Display Panel




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