MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride caps

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)

Available from:

RB Health (US) LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure cough - nasal congestion - headache - minor aches and pains - sinus congestion and pressure - cough - temporarily promotes nasal and/or sinus drainage

Authorization status:

OTC monograph final

Summary of Product characteristics

MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN- ACETAMINOPHEN,
DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE
CAPSULE, LIQUID FILLED
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® SINUS-MAX®
SEVERE CONGESTION & PAIN
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH LIQUID GEL)_
_PURPOSES_
ACETAMINOPHEN 325 MG
PAIN RELIEVER
Dextromethorphan HBr 10 mg
Cough suppressant
Phenylephrine HCl 5 mg
Nasal decongestant
US ES
temporarily relieves:
nasal congestion
headache
minor aches and pains
sinus congestion and pressure
cough
temporarily promotes nasal and/or sinus drainage
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take:
more than 12 liquid gels 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.
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
contains an MAOI, ask a
doctor or pharmacist before taking this product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
heart disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or
emphysema
cough that occurs with too much phlegm (mucus)
ASK A DOCTOR OR P