MUCINEX CHILDRENS MULTI-SYMPTOM COUGH, COLD AND FEVER- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephr

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), Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ), Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)

Available from:

RB Health (US) LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold and flu symptoms: nasal congestion stuffy nose cough due to minor throat and bronchial irritation the intensity of coughing the impulse to cough to help your child get to sleep minor aches and pains sore throat headache - nasal congestion - stuffy nose - cough due to minor throat and bronchial irritation - the intensity of coughing - the impulse to cough to help your child get to sleep - minor aches and pains - sore throat - headache - temporarily reduces fever - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Authorization status:

OTC monograph final

Summary of Product characteristics

MUCINEX CHILDRENS MULTI-SYMPTOM COUGH, COLD AND FEVER-
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND
PHENYLEPHRINE 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 CHILDREN'S
MULTI-SYMPTOM COUGH, COLD & FEVER
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN_
_EACH 10 ML)_
_PURPOSES_
ACETAMINOPHEN 325
MG
PAIN RELIEVER/FEVER
REDUCER
Dextromethorphan HBr
10 mg
Cough suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCl 5 mg
Nasal decongestant
USES
temporarily relieves these common cold and flu symptoms:
nasal congestion
stuffy nose
cough due to minor throat and bronchial irritation
the intensity of coughing
the impulse to cough to help your child get to sleep
minor aches and pains
sore throat
headache
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus and make coughs more productive
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
your child
takes:
more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
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.
in a child who is taking a prescription monoamine oxidase inhibitor
(MAOI) (certain
drugs for depression, psychiatric, or emotional conditions, or
Parkinson's disease),
or for 2