ULTRA TUSS DM
(guaifenesin dextromethorphan hbr)
[Ultra Seal Corporation]
|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
• A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
• 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.
• Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.
• 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 MAOI drug. If you do not know if your prescription
drug contains an MAOI, consult a doctor or pharmacist before
taking this product
Stop use and ask a doctor if:
• symptoms do not improve
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by
• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
Ask a doctor before use if you have:
• heart disease
• high blood pressure
• thyroid disease
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
Adults and children 12 years of age and older
• Take 2 teaspoons (10 ml) every 4 hours as needed, do not exceed 12
teaspoons in 24 hours, or as directed by a doctor.
• Children 6-12 years, Take 1 teaspoon ( 5 ml) every 4 hours as needed, do not exceed 6 teaspoons in 24 hours, or as directed by a doctor.
• Children 2-6 years, Take 1/2 teaspoon ( 2.5 ml) every 4 hours as needed, do not exceed 3 teaspoons in 24 hours, or as directed by a doctor.
• Children under 2 years, consult a physician
|ULTRA TUSS DM
guaifenesin dextromethorphan hbr syrup
|Labeler - Ultra Seal Corporation (085752004)|
|Registrant - Ultra Seal Corporation (085752004)|
|ULTRAtab Laboratories, Inc.||151051757||manufacture|