Maximum Strength Mucinex® Fast-max ®

Maximum Strength Mucinex® Fast-max ®
SPL v6
SPL
SPL Set ID 19da539e-7b57-41d7-aad5-fc89a6705e20
Route
ORAL
Published
Effective Date 2021-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Lecithin, Soybean Mineral Oil Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Shellac Titanium Dioxide Sorbitan Sorbitol D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: VVV;CF Shape: oval Color: orange Color: green Size: 24 mm Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-28
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses
  • temporarily relieves these common cold and flu symptoms:
    • sinus congestion and pressure
    • cough
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • runny nose (NIGHT only)
    • sneezing (NIGHT only)
    • itching of the nose or throat (NIGHT only)
    • itchy, watery eyes due to hay fever (NIGHT only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
  • controls cough to help you get to sleep
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each liquid gel) Purposes
Mucinex FAST-MAX DAY Cold & Flu
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 12 liquid gels in any 24-hour period
  • adults and children 12 years of age and over: take 2 liquid gels 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.
  • 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.

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.

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
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.

Other Information
  • store at 20-25°C (68-77°F)
  • avoid excessive heat
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.

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children (NIGHT only)
  • marked drowsiness may occur (NIGHT only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
  • avoid alcoholic drinks (NIGHT only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT only)
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Inactive Ingredients (day Only)

FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Inactive Ingredients (night Only)

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

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
  • glaucoma (NIGHT only)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT 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

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH



NDC 63824-519-24

Mucinex®



FAST-MAX ®

DAY



COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Guaifenesin – Expectorant



Phenylephrine HCl – Nasal Decongestant

HEADACHE



BODY PAIN

SORE THROAT



FEVER

CHEST CONGESTION



COUGH

ALL IN



ONE *

NASAL CONGESTION



SINUS CONGESTION

SINUS PRESSURE

16

LIQUID GELS



(Liquid Filled



Capsules)

NIGHT



COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Doxylamine succinate - Antihistamine



Phenylephrine HCl – Nasal Decongestant

HEADACHE



BODY PAIN

SORE THROAT



FEVER

ITCHY THROAT



COUGH

ALL IN



ONE *

NASAL CONGESTION



SNEEZING

RUNNY NOSE

8

LIQUID GELS



(Liquid Filled



Capsules)

24 TOTAL



AGES 12+

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (NIGHT only)

Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • sinus congestion and pressure
    • cough
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • runny nose (NIGHT only)
    • sneezing (NIGHT only)
    • itching of the nose or throat (NIGHT only)
    • itchy, watery eyes due to hay fever (NIGHT only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
  • controls cough to help you get to sleep
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 liquid gel) Purposes
Mucinex FAST-MAX DAY Cold & Flu
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 12 liquid gels in any 24-hour period
  • adults and children 12 years of age and over: take 2 liquid gels 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.
  • 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.

Allergy Alert (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.

Liver Warning (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
Overdose Warning (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.

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat
Sore Throat Warning (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.

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children (NIGHT only)
  • marked drowsiness may occur (NIGHT only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
  • avoid alcoholic drinks (NIGHT only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT only)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Inactive Ingredients (day Only) (Inactive ingredients (DAY only))

FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Inactive Ingredients (night Only) (Inactive ingredients (NIGHT only))

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Ask A Doctor Before Use If You Have (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
  • glaucoma (NIGHT only)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT 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)

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH



NDC 63824-519-24

Mucinex®



FAST-MAX ®

DAY



COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Guaifenesin – Expectorant



Phenylephrine HCl – Nasal Decongestant

HEADACHE



BODY PAIN

SORE THROAT



FEVER

CHEST CONGESTION



COUGH

ALL IN



ONE *

NASAL CONGESTION



SINUS CONGESTION

SINUS PRESSURE

16

LIQUID GELS



(Liquid Filled



Capsules)

NIGHT



COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Doxylamine succinate - Antihistamine



Phenylephrine HCl – Nasal Decongestant

HEADACHE



BODY PAIN

SORE THROAT



FEVER

ITCHY THROAT



COUGH

ALL IN



ONE *

NASAL CONGESTION



SNEEZING

RUNNY NOSE

8

LIQUID GELS



(Liquid Filled



Capsules)

24 TOTAL



AGES 12+

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
  • taking sedatives or tranquilizers (NIGHT only)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:52.791578 · Updated: 2026-03-14T23:05:59.331876