VICKS SINEX SEVERE CONGESTION- acetaminophen, phenylephine hcl, and guaifenesin capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

The Procter & Gamble Manufacturing Company

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporarily relieves symptoms due to the common cold (or a cold) - minor aches and pains - headache - fever - nasal congestion - sinus congestion & pressure - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus - temporarily relieves symptoms due to hay fever or other upper respiratory allergies - minor aches and pains - headache - nasal congestion - sinus congestion & pressure

Authorization status:

OTC monograph final

Summary of Product characteristics

VICKS SINEX SEVERE CONGESTION- ACETAMINOPHEN, PHENYLEPHINE HCL, AND
GUAIFENESIN CAPSULE, LIQUID FILLED
THE 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
SINEX ™
SEVERE
CONGESTION
LIQUICAPS
LIQUICAPS
_DRUG FACTS_
ACTIVE INGREDIENTS (IN EACH LIQUICAP)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
PURPOSE
Pain reliever/fever reducer
Expectorant
Nasal decongestant
US ES
temporarily relieves symptoms due to the common cold (or a cold)
minor aches and pains
headache
fever
nasal congestion
sinus congestion & pressure
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial passageways of
bothersome mucus
temporarily relieves symptoms due to hay fever or other upper
respiratory allergies
minor aches and pains
headache
nasal congestion
sinus congestion & pressure
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take
more than 8 LiquiCaps in 24 hours, which is the maximum daily amount
for this product
®
with other drugs containing acetaminophen
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
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
(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.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver dis