|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive. restores free breathing.
suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
• use more than the recommended dose
• give this product to a child who has heart disease, high blood pressure, thyroid
disease, or diabetes unless directed by a doctor.
• 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.
• diabetes • heart disease • thyroid disease • high blood pressure • trouble
urinating due to an enlarged 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 before use if you have
When using this product do not use more than directed
Stop use and ask a doctor if
•you get nervous, dizzy, or sleepless
•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.
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
Inactives: Citric Acid, FDC Red 40, Flavor, Glycerin, Methylparaben, propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sucralose
guaifenesin,dextromethorphan hydrobromide syrup
|Labeler - KRAMER NOVIS (090158395)|
|Registrant - KRAMER NOVIS (090158395)|
|ULTRAtab Laboratories, Inc.||151051757||manufacture(52083-620)|
|Ultra Seal Corporation||085752004||repack(52083-620)|