VIRTUSSIN AC W/ALC- codeine phosphate and guaifenesin 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)

Available from:

Virtus Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

VIRTUSSIN AC W/ALC- CODEINE PHOSPHATE AND GUAIFENESIN LIQUID
VIRTUS PHARMACEUTICALS LLC
_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 AC W/ALC
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(IN EACH 5 ML = 1 TSP)_
_PURPOSE_
Codeine phosphate, USP 10 mg
Cough suppressant
Guaifenesin, USP 100 mg
Expectorant
_USES_
▪
_WARNINGS_
ASK YOUR DOCTOR BEFORE USE IF
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WHEN USING THIS PRODUCT
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STOP USE AND ASK A DOCTOR IF
temporarily relieves:
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cough due to minor throat and bronchial irritation as may occur with a
cold or
inhaled irritants
your cough to help you sleep
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus and make cough more productive.
you have a persistent cough, this may be a sign of a serious condition
you have a persistent cough such as occurs with smoking, asthma,
chronic
bronchitis or emphysema
you have a cough that is accompanied by excessive phlegm (mucus)
you have chronic pulmonary disease or shortness of breath
giving to a child who is taking other drugs
giving a higher dose than recommended by a doctor could result in
serious side
effects for your child. A special measuring device should be used to
give an
accurate dose of this product to children under 6 years of age.
may cause or aggravate constipation
▪
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_
▪
Adults and children 12 years of age and
over:
2 tsp (10 mL) every 4 hours,
or as directed by a doctor.
Children 6 to under 12 years of age:
1 tsp (5 mL) every 4 hours,
or as directed by a doctor.
Children under 6 years of age:
Consult a doctor.
_OTHER INFORMATION_
Each tsp (5 mL) contains 4 mg sodium.
Store at controlled room tem