VICKS SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)

Available from:

Procter & Gamble Manufacturing Company

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporarily relieves common cold/flu symptoms: - nasal congestion - sinus congestion & pressure - cough due to minor throat & bronchial irritation - cough to help you sleep - minor aches & pains - headache - fever - sore throat - runny nose & sneezing - reduces swelling of nasal passages - temporarily restores freer breathing through the nose - promotes nasal and/or sinus drainage

Authorization status:

OTC monograph final

Summary of Product characteristics

VICKS SEVERE COLD AND FLU- ACETAMINOPHEN, DEXTROMETHORPHAN HBR,
DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL LIQUID
PROCTER & GAMBLE MANUFACTURING COMPANY
_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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VICKS NYQUIL SEVERE COLD & FLU HONEY
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH 15 ML)_
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
_USES_
temporarily relieves common cold/flu symptoms:
nasal congestion
sinus congestion & pressure
cough due to minor throat & bronchial irritation
cough to help you sleep
minor aches & pains
headache
fever
sore throat
runny nose & sneezing
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
_WARNINGS_
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
adult takes more than 4 doses (30 mL each) in 24 hours, which is the
maximum daily
amount for this product
child takes more than 4 doses (15 mL each) in 24 hours, which is the
maximum daily
amount for this product
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks daily while using this product
ALLERGY ALERT:
Acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening
blisters
rash
If a skin reaction occurs, stop use and seek medical help right away
SORE THROAT WARNING
If sore throat is severe, persists for more than 2 days, is
accompanied or is followed by
fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
DO NOT USE
with any other drug containing acetaminophen (prescription or
nonprescription). If
you are not sure whether a drug contains acetaminophen, ask a doctor
or
pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor
(MA