MUCINEX FAST-MAX COLD AND SINUS- acetaminophen, guaifenesin, and phenylephrine hydrochloride liquid

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:

RB Health (US) LLC

INN (International Name):

Acetaminophen

Composition:

Acetaminophen 650 mg in 20 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold and flu symptoms: minor aches and pains sore throat headache nasal congestion sinus congestion and pressure - minor aches and pains - sore throat - headache - nasal congestion - sinus congestion and pressure - 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 FAST-MAX COLD AND SINUS- ACETAMINOPHEN, GUAIFENESIN, AND
PHENYLEPHRINE
HYDROCHLORIDE LIQUID
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 FAST-MAX™
COLD & SINUS
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(IN EACH 20 ML)_
_PURPOSE_
ACETAMINOPHEN 650 MG
PAIN RELIEVER/FEVER REDUCER
Guaifenesin 400 mg
Expectorant
Phenylephrine HCl 10 mg
Nasal decongestant
US ES
temporarily relieves these common cold and flu symptoms:
minor aches and pains
sore throat
headache
nasal congestion
sinus congestion and pressure
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
you take:
more than 6 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily 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.
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.
for children under 12 years of age
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 precscription drug
contains an MAOI, ask a
doctor or pharmacist before taking this product.
®
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chro