FDA Label for Safetussin DM

View Indications, Usage & Precautions

Safetussin DM Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Laboratories. 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



Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg


Otc - Purpose



Cough suppressant

Expectorant


Otc - Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center right away


Indications & Usage



temporarily relieves cough due to minor throat and bronchial irritation  
loosen phlegm (mucus)
helps rid bronchial passages of phlegm (mucus)


Dosage & Administration



do not take more than 6 doses in any 24-hour period
this adult product is not intended for use in children under 12 years of age

Adults and children 12 years and over 2 teaspoons every 4 hours
children under 12 years do not use


Inactive Ingredient



aspartame ,benzoic acid, citric acid, glycerin,methol,methylparaben,nautral pepermint flavor,propylene glycol,propylparaben,
,purified water 


Warnings




Do not use
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
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

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.

If pregnant or breast-feeding,

ask a health professional before use.


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