NIGHTTIME RELIEF SEVERE COLD AND FLU- acetaminophen, doxylamine succinate, phenylephrine hcl and dextromethorphan hbr solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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)

Verfügbar ab:

Fred's, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Active ingredients (in each 30 mL dose cup)                             Purpose Acetaminophen USP 650 mg .............................................. Pain reliever/fever reducer Dextromethorphan HBr USP 20 mg ............................................... Cough suppressant Doxylamine succinate USP 12.5 mg ........................................................ Antihistamine Phenylephrine HCl USP 10 mg ...................................................... Nasal decongestant 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 - with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask

Berechtigungsstatus:

OTC monograph final

Fachinformation

NIGHTTIME RELIEF SEVERE COLD AND FLU - ACETAMINOPHEN, DOXYLAMINE
SUCCINATE,
PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR SOLUTION
FRED'S, 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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DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 30 ML DOSE CUP) PURPOSE
Acetaminophen USP 650 mg
.............................................. Pain reliever/fever
reducer
Dextromethorphan HBr USP 20 mg
............................................... Cough suppressant
Doxylamine succinate USP 12.5 mg
........................................................ Antihistamine
Phenylephrine HCl USP 10 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 (120 mL) 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
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
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 tak