The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Fast-max Cold And Flu (NDC 72854-171). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, otc - active ingredient, indications & usage, warnings, dosage & administration, other safety information, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Purpose Day:
Acetaminophen 325 mg...Pain reliever/fever reducer
Dextromethorphan HBr 10 mg.......Cough suppressant
Purpose Night:
Acetaminophen 325 mg...Pain reliever/fever reducer
Dextromethorphan HBr 10 mg.......Cough suppressant
Doxylamine succinate 6.25 mg............. Antihistamine
Day:
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Night:
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Day:
■ temporarily relieves these common cold and flu
symptoms:
■ cough due to minor throat and bronchial
irritation as may occur with the common cold or
inhaled irritants
■ the intensity of coughing
■ the impulse to cough to help you get to sleep
■ minor aches and pains ■ sore throat
■ headache
■ temporarily reduces fever
Night:
■ temporarily relieves these common cold and flu
symptoms:
■ cough ■ minor aches and pains
■ sore throat ■ headache ■ 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
Day:
Liver warning: This product contains
acetaminophen. Severe liver damage may occur if
you take:
■ more than 12 capsules in 24 hours, which is the
maximum daily amount for this product
■ 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 contains an MAOI, ask a
doctor or pharmacist before taking this product.
Ask a doctor before use if you have
■ liver disease
■ persistent or chronic cough such as occurs with
smoking, asthma, or emphysema
■ cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
When using this product do not use more than
directed
Stop use and ask a doctor if
■ pain or cough gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
■ cough comes back or occurs with rash or
headache that lasts. These could be signs of a
serious condition.
Overdose warning: Taking more than the
recommended dose (overdose) may cause liver
damage. In case of overdose, get medical help or
contact a Poison Control Center right away. Quick
medical attention is critical for adults as well as
for children even if you do not notice any signs or
symptoms.
Night:
Severe liver damage may occur if you take:
■ more than 12 capsules in 24 hours, which is the
maximum daily amount for this product
■ 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 contains an MAOI, ask a
doctor or pharmacist before taking this product.
Ask a doctor before use if you have
■ liver disease ■ glaucoma
■ trouble urinating due to an enlarged prostate
gland
■ a breathing problem such as emphysema or
chronic bronchitis
■ persistent or chronic cough such as occurs with
smoking, asthma, or emphysema
■ cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
When using this product
■ do not use more than directed
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may
increase drowsiness
■ avoid alcoholic drinks
■ use caution when driving a motor vehicle or
operating machinery
Day:
Directions
■ do not take more than directed (see Overdose
warning)
■ do not take more than 12 capsules in any 24-hour
period
■ adults and children 12 years of age and over: take 2
capsules every 4 hours
■ children under 12 years of age: do not use
Night:
Directions
■ do not take more than directed (see Overdose
warning)
■ do not take more than 12 capsules in any 24-hour
period
■ adults and children 12 years of age and over: take 2
capsules every 4 hours
■ children under 12 years of age: do not use
Other information
■ store at 20-25°C (68-77°F)
■ avoid excessive heat
If pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the
recommended dose (overdose) may cause liver
damage. In case of overdose, get medical help or
contact a Poison Control Center right away. Quick
medical attention is critical for adults as well as for
children even if you do not notice any signs or
symptoms.
Day:
FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin,
hypromellose, isopropyl alcohol, lecithin (sunflower),
light mineral oil, mannitol, polyethylene glycol 400,
povidone, propylene glycol, purified water, 1,4-sorbitan,
sorbitol, titanium dioxide
Night:
D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin,
hypromellose, isopropyl alcohol, lecithin (sunflower),
light mineral oil, mannitol, polyethylene glycol 400,
povidone, propylene glycol, purified water, 1,4-sorbitan,
sorbitol, titanium dioxide
Questions? 1-866-MUCINEX (1-866-682-4639)
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