FDA Label for Supress Dm

View Indications, Usage & Precautions

Supress Dm Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Novis. 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 Ingredients in each 1 ml: Guaifenesin 50 mg, dextromethorphan hydrobromide 5 mg


Otc - Purpose



Cough Suppressant, Expectorant


Indications & Usage



suppresses cough due to minor throat and bronchial irritation associated with
a cold or inhaled irritants
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial
passages of bothersome mucus, drain bronchial tubes, and make coughs
more productive


Warnings



WarningsDo not use if if a child is 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 for:A cough that occurs with too much phlegm (mucus)-Cough that lasts or is chronic such as occurs with asthma

Stop use and ask a doctor if: new symptoms occur•symptoms do not get better within 7 days or are accompanied by fever
•coughs lasts more than 7 days, comes back, or is accompanied by fever,
rash, or a persistent headache. These could be signs of a serious condition



Otc - Keep Out Of Reach Of Children



Keep this and all medicines out of the reach of children


Otc - Pregnancy Or Breast Feeding



As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product


Inactive Ingredient



Inactives: Citric Acid, Cherry FlavorFlavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl
Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin.


Package Label.Principal Display Panel



MM1


Dosage & Administration



Children 2-6 years, 1 mL every 4 hours as needed, Do not exceed 6 doses in any 24-hour, or as directed by a doctor

Children under 2 years, consult a doctor

neasure with the dosage device provided.  Do not use with any other device.


* Please review the disclaimer below.