SEVERE NIGHTTIME COLD AND FLU

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Produktets egenskaber Produktets egenskaber (SPC)
14-01-2020

Aktiv bestanddel:

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

Tilgængelig fra:

Wal-Mart Stores Inc

Indgivelsesvej:

ORAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

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

Autorisation status:

OTC monograph final

Produktets egenskaber

                                SEVERE NIGHTTIME COLD AND FLU- ACETAMINOPHEN, DEXTROMETHORPHAN
HYDROBROMIDE,
DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE CAPSULE, GELATIN
COATED
WAL-MART STORES INC
_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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SEVERE NIGHTTIME COLD AND FLU
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH SOFTGEL)_
_PURPOSES_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Dextromethorphan HBr 10 mg
Cough suppressant
Doxylamine succinate 6.25 mg
Antihistamine
Phenylephrine HCl 5 mg
Nasal decongestant
US ES
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
you take
more than 4 doses in 24 hours, which is the maximum daily amount for
this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
SORE THROAT WARNING
If sore throat is severe, persists for more than 2 days, is
accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly.
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
stopp
                                
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