MUCINEX NIGHTSHIFT SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)

Available from:

RB Health (US) LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache sinus congestion and pressure runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever - cough - nasal congestion - minor aches and pains - sore throat - headache - sinus congestion and pressure - runny nose - sneezing - itching of the nose or throat - itchy, watery eyes due to hay fever - temporarily reduces fever - controls cough to help you get to sleep

Authorization status:

OTC monograph final

Summary of Product characteristics

MUCINEX NIGHTSHIFT SEVERE COLD AND FLU- ACETAMINOPHEN,
DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND
TRIPROLIDINE HYDROCHLORIDE SOLUTION
RB HEALTH (US) 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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MUCINEX® NIGHTSHIFT SEVERE COLD AND FLU
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN_
_EACH 20 ML)_
_PURPOSES_
ACETAMINOPHEN 650
MG
PAIN RELIEVER/FEVER
REDUCER
Dextromethorphan HBr
20 mg
Cough suppressant
Phenylephrine HCl 10 mg
Nasal decongestant
Triprolidine HCl 2.5 mg
Antihistamine
USES
temporarily relieves these common cold and flu symptoms:
cough
nasal congestion
minor aches and pains
sore throat
headache
sinus congestion and pressure
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes due to hay fever
temporarily reduces fever
controls cough to help you get to sleep
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take:
more than 4000 mg in 24 hours, which is the maximum daily amount
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.
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 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 co