Mucinex® Fast-max ®
3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
Uses
Mucinex Fast-Max Severe Congestion & Cough
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid
the bronchial passageways of bothersome mucus and make
coughs more productive
■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as may
occur with the common cold or inhaled irritants
■ the intensity of coughing ■ nasal congestion due to a cold
■ temporarily helps you cough less
Mucinex Nighttime Cold & Flu
■ 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
Section 42229-5
Drug Facts
Section 43683-2
Mucinex Fast-Max Severe Congestion & Cough Clear & Cool
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid
the bronchial passageways of bothersome mucus and make
coughs more productive
■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as may
occur with the common cold or inhaled irritants
■ the intensity of coughing ■ nasal congestion due to a cold
■ temporarily helps you cough less
Mucinex Nightshift Cold & Flu Clear & Cool
■ 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
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
|
Active ingredients (in each 20 mL)
Mucinex Fast-Max Severe Congestion & Cough |
Purposes |
|---|---|
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
|
Active ingredients (in each 20 mL)
Mucinex Nightshift Cold & Flu |
Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Triprolidine HCl 2.5 mg | Antihistamine |
Section 55106-9
Dextromethorphan HBr 20 mg..............Cough suppressant
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant
Acetaminophen 650mg..........Pain reliever/fever reducer
Dextromethorphan HBr 20 mg..............Cough suppressant
Phenylephrine HCl 10 mg. . . . . . . . . . . . . . . . . Nasal decongestant
Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . . Antihistamine
Warnings
Liver warning (Nighttime Cold & Flu only): 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 (Nighttime Cold & Flu only):
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 (Nighttime Cold & Flu only): 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.
Directions
Mucinex Fast-Max Severe Congestion & Cough
Clear & Cool
■ do not take more than 6 doses in any 24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and over: 20 mL in dosing
cup provided every 4 hours
■ children under 12 years of age: do not use
Mucinex Nighttime Cold & Flu
■ do not take more than directed (see Overdose warning)
■ do not take more than 4 doses in any 24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and over: 20 mL in dosing cup
provided every 4 hours
■ children under 12 years of age: do not use
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. (Nightshift Cold & Flu only)
- 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.
Questions?
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
Other Information
■ each 20 mL contains: sodium
9 mg (Fast-Max Severe
Congestion & Cough only) and sodium 16 mg
(Nighttime Cold & Flu l only)
■ store at 20-25°C (68-77°F)
■ do not refrigerate
When Using This Product
- do not use more than directed
- excitability may occur, especially in children (Nightshift Cold & Flu only)
- marked drowsiness may occur (Nightshift Cold & Flu only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu only)
- avoid alcoholic drinks (Nightshift Cold & Flu only)
- use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu only)
Stop Use and Ask A Doctor If
- pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only)
- fever gets worse or lasts more than 3 days (Nightshift Cold & Flu only)
- redness or swelling is present (Nightshift Cold & Flu only)
- new symptoms occur (Nightshift Cold & Flu only)
- cough comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Cold & Flu only)
- nervousness, dizziness, or sleeplessness occur (Fast-Max Severe Congestion & Cough only)
- symptoms do not get better within 7 days or occur with fever (Fast-Max Severe Congestion & Cough only)
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Fast-Max Severe Congestion & Cough only)
Mucinex Nightshift Cold & Flu
- 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
Ask A Doctor Before Use If You Have
- liver disease (Nightshift Cold & Flu only)
- heart disease (Fast-Max Severe Congestion & Cough only)
- high blood pressure (Fast-Max Severe Congestion & Cough only)
- thyroid disease (Fast-Max Severe Congestion & Cough only)
- diabetes (Fast-Max Severe Congestion & Cough only)
- glaucoma (Nightshift Cold & Flu only)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Principal Display Panel Kit Carton
DAY & NIGHT
COUGH & COLD RELIEF
MAXIMUM STRENGTH
NDC 72854-166-26
Mucinex®
FAST-MAX
®
SEVERE CONGESTION
& COUGH
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
- Controls Cough
- Relieves Nasal & Chest Congestion
- Thins & Loosens Mucus
Mucinex®
NIGHTTIME
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – Antihistamine
NIGHTTIME
RELIEF FOR A BETTER
MORNING
✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING
FOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)
FOR
AGES 12+
Allergy Alert (nightshift Cold & Flu Only)
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.
Liver Warning (nightshift Cold & Flu Only)
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
Mucinex Fast Max Severe Congestion & Cough
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- nasal congestion due to a cold
- the impulse to cough to help you get to sleep
Overdose Warning (nightshift Cold & Flu Only)
Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin (Nightshift Cold & Flu only)
- taking sedatives or tranquilizers (Nightshift Cold & Flu only)
Sore Throat Warning (nightshift Cold & Flu Only)
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.
Inactive Ingredients (mucinex Nighttime Cold & Flu)
ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blueno.1, FD&Credno.40, flavor, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Inactive Ingredients (mucinex Fast Max Severe Congestion & Cough)
ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate*, xanthan gum *may contain this ingredient
Structured Label Content
Uses
Mucinex Fast-Max Severe Congestion & Cough
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid
the bronchial passageways of bothersome mucus and make
coughs more productive
■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as may
occur with the common cold or inhaled irritants
■ the intensity of coughing ■ nasal congestion due to a cold
■ temporarily helps you cough less
Mucinex Nighttime Cold & Flu
■ 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
Section 42229-5 (42229-5)
Drug Facts
Section 43683-2 (43683-2)
Mucinex Fast-Max Severe Congestion & Cough Clear & Cool
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid
the bronchial passageways of bothersome mucus and make
coughs more productive
■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as may
occur with the common cold or inhaled irritants
■ the intensity of coughing ■ nasal congestion due to a cold
■ temporarily helps you cough less
Mucinex Nightshift Cold & Flu Clear & Cool
■ 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
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
|
Active ingredients (in each 20 mL)
Mucinex Fast-Max Severe Congestion & Cough |
Purposes |
|---|---|
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
|
Active ingredients (in each 20 mL)
Mucinex Nightshift Cold & Flu |
Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Triprolidine HCl 2.5 mg | Antihistamine |
Section 55106-9 (55106-9)
Dextromethorphan HBr 20 mg..............Cough suppressant
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant
Acetaminophen 650mg..........Pain reliever/fever reducer
Dextromethorphan HBr 20 mg..............Cough suppressant
Phenylephrine HCl 10 mg. . . . . . . . . . . . . . . . . Nasal decongestant
Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . . Antihistamine
Warnings
Liver warning (Nighttime Cold & Flu only): 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 (Nighttime Cold & Flu only):
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 (Nighttime Cold & Flu only): 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.
Directions
Mucinex Fast-Max Severe Congestion & Cough
Clear & Cool
■ do not take more than 6 doses in any 24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and over: 20 mL in dosing
cup provided every 4 hours
■ children under 12 years of age: do not use
Mucinex Nighttime Cold & Flu
■ do not take more than directed (see Overdose warning)
■ do not take more than 4 doses in any 24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and over: 20 mL in dosing cup
provided every 4 hours
■ children under 12 years of age: do not use
Do Not Use (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. (Nightshift Cold & Flu only)
- 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.
Questions?
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
Other Information (Other information)
■ each 20 mL contains: sodium
9 mg (Fast-Max Severe
Congestion & Cough only) and sodium 16 mg
(Nighttime Cold & Flu l only)
■ store at 20-25°C (68-77°F)
■ do not refrigerate
When Using This Product (When using this product)
- do not use more than directed
- excitability may occur, especially in children (Nightshift Cold & Flu only)
- marked drowsiness may occur (Nightshift Cold & Flu only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu only)
- avoid alcoholic drinks (Nightshift Cold & Flu only)
- use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu only)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only)
- fever gets worse or lasts more than 3 days (Nightshift Cold & Flu only)
- redness or swelling is present (Nightshift Cold & Flu only)
- new symptoms occur (Nightshift Cold & Flu only)
- cough comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Cold & Flu only)
- nervousness, dizziness, or sleeplessness occur (Fast-Max Severe Congestion & Cough only)
- symptoms do not get better within 7 days or occur with fever (Fast-Max Severe Congestion & Cough only)
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Fast-Max Severe Congestion & Cough only)
Mucinex Nightshift Cold & Flu (MUCINEX NIGHTSHIFT COLD & FLU)
- 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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease (Nightshift Cold & Flu only)
- heart disease (Fast-Max Severe Congestion & Cough only)
- high blood pressure (Fast-Max Severe Congestion & Cough only)
- thyroid disease (Fast-Max Severe Congestion & Cough only)
- diabetes (Fast-Max Severe Congestion & Cough only)
- glaucoma (Nightshift Cold & Flu only)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)
DAY & NIGHT
COUGH & COLD RELIEF
MAXIMUM STRENGTH
NDC 72854-166-26
Mucinex®
FAST-MAX
®
SEVERE CONGESTION
& COUGH
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
- Controls Cough
- Relieves Nasal & Chest Congestion
- Thins & Loosens Mucus
Mucinex®
NIGHTTIME
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – Antihistamine
NIGHTTIME
RELIEF FOR A BETTER
MORNING
✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING
FOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)
FOR
AGES 12+
Allergy Alert (nightshift Cold & Flu Only) (Allergy alert (Nightshift Cold & Flu only))
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.
Liver Warning (nightshift Cold & Flu Only) (Liver warning (Nightshift Cold & Flu only))
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
Mucinex Fast Max Severe Congestion & Cough (MUCINEX FAST-MAX SEVERE CONGESTION & COUGH)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- nasal congestion due to a cold
- the impulse to cough to help you get to sleep
Overdose Warning (nightshift Cold & Flu Only) (Overdose warning (Nightshift Cold & Flu only))
Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
- taking the blood thinning drug warfarin (Nightshift Cold & Flu only)
- taking sedatives or tranquilizers (Nightshift Cold & Flu only)
Sore Throat Warning (nightshift Cold & Flu Only) (Sore throat warning (Nightshift Cold & Flu only))
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.
Inactive Ingredients (mucinex Nighttime Cold & Flu) (Inactive ingredients (Mucinex Nighttime Cold & Flu))
ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blueno.1, FD&Credno.40, flavor, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Inactive Ingredients (mucinex Fast Max Severe Congestion & Cough) (Inactive ingredients (Mucinex Fast-Max Severe Congestion & Cough))
ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate*, xanthan gum *may contain this ingredient
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Source: dailymed · Ingested: 2026-02-15T12:06:38.876730 · Updated: 2026-03-14T23:09:33.254922