VIRTUSSIN DAC- codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

Virtus Pharmaceuticals

Administration route:

ORAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

VIRTUSSIN DAC- CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE
HYDROCHLORIDE LIQUID
VIRTUS PHARMACEUTICALS
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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VIRTUSSIN DAC
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(IN EACH 5 ML = 1 TSP)_
_PURPOSE_
Codeine phosphate, USP 10 mg
Cough Suppressant
Guaifenesin, USP 100 mg
Expectorant
Pseudoephedrine HCl, USP 30 mg
Nasal Decongestant
_USES_
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_WARNINGS_
ASK YOUR DOCTOR BEFORE USE IF YOU HAVE
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DO NOT USE
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temporarily relieves cough due to minor throat and bronchial
irritation as may occur
with a cold
temporarily relieves nasal congestion due to the common cold
temporarily restores freer breathing through the nose
helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more
productive
calms the cough control center and relieves coughing
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to enlarged prostate gland
cough that occurs with excessive phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma,
chronic
bronchitis, or emphysema
in a child under 2 years of age
if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain
drugs for depression, psychiatric, or emotional conditions, or
Parkinson's disease),
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WHEN USING THIS PRODUCT
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STOP USE AND ASK A DOCTOR IF
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IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose, get medical
help or contact
a Poison Control Center right away.
_DIRECTIONS_
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_OTHER INFORMATION_
Each tsp (5 mL) contains 3 mg sodium.
Store at controlled room temperature 15°-30°C (59°-86°F).
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
produc