Mucinex® Fast-max ®

SPL v5

SPL

SPL Set ID 3ba2cc08-acad-79a8-e063-6394a90af17f

Route

ORAL

Published

Effective Date 2022-06-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Triprolidine (2.5 mg) Guaifenesin (400 mg)

Inactive Ingredients

Glycerin Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Propylene Glycol Sodium Benzoate Sorbitol Sucralose Water Xanthan Gum Ammonium Glycyrrhizate Propyl Gallate Trisodium Citrate Dihydrate

Identifiers & Packaging

Pill Appearance

Color: blue Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

the impulse to cough to help you get to sleep

Section 42229-5

Drug Facts

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 DM MAX	Purposes
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant

Active ingredients (in each 20 mL) MUCINEX NIGHTTIME 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

Active ingredients (in each 20 mL)

MUCINEX FAST-MAX DM MAX

Dextromethorphan HBr 20 mg Cough suppressant

Guaifenesin 400 mg Expectorant

Active ingredients (in each 20 mL)

MUCINEX NIGHTTIME COLD & FLU Purposes

Acetaminophen 650 mg Pain reliever/fever reducer

Dextromethorphan HBr 20 mg Cough suppressant

Triprolidine HCl 2.5 mg Antihistamine

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 12 mg (Fast-Max DM Max only) and sodium 16 mg (Nightshift Cold & Flu only)
store at 20-25°C (68-77°F)
do not refrigerate

Mucinex Fast Max Dm Max

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
- the impulse to cough to help you get to sleep

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)
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 DM Max 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)
glaucoma (Nightshift Cold & Flu only)
trouble urinating due to an enlarged prostate gland (Nightshift Cold & Flu only)
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 72854-165-26

Mucinex®

FAST-MAX ^®

DM MAX

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Controls Cough
Relieves Chest Congestion
Thins & Loosens Mucus
4 Hour Dosing

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

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.

Inactive Ingredients (mucinex Fast Max Dm Max)

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

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 Nightshift Cold & Flu)

ammonium glycyrrhizate, anhydrous citric acid, edetate

disodium, FD&C blue no. 1, FD&C red no.

40, flavor, glycerin (soy), propylene glycol,

purified water, sodium benzoate, sorbitol,

sucralose, xanthan gum

Structured Label Content

Uses

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

the impulse to cough to help you get to sleep

Section 42229-5 (42229-5)

Drug Facts

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 DM MAX	Purposes
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant

Active ingredients (in each 20 mL) MUCINEX NIGHTTIME 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)

Active ingredients (in each 20 mL)

MUCINEX FAST-MAX DM MAX

Dextromethorphan HBr 20 mg Cough suppressant

Guaifenesin 400 mg Expectorant

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 12 mg (Fast-Max DM Max only) and sodium 16 mg (Nightshift Cold & Flu only)
store at 20-25°C (68-77°F)
do not refrigerate

Mucinex Fast Max Dm Max (MUCINEX FAST-MAX DM MAX)

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
- the impulse to cough to help you get to sleep

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)
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 DM Max 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)
glaucoma (Nightshift Cold & Flu only)
trouble urinating due to an enlarged prostate gland (Nightshift Cold & Flu only)
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 72854-165-26

Mucinex®

FAST-MAX ^®

DM MAX

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Controls Cough
Relieves Chest Congestion
Thins & Loosens Mucus
4 Hour Dosing

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

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.

Inactive Ingredients (mucinex Fast Max Dm Max) (Inactive ingredients (MUCINEX FAST-MAX DM MAX))

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 Nightshift Cold & Flu) (Inactive ingredients (MUCINEX NIGHTSHIFT COLD & FLU))

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "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 the impulse to cough to help you get to sleep", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 20 mL) MUCINEX FAST-MAX DM MAX Purposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Active ingredients (in each 20 mL) MUCINEX NIGHTTIME COLD & FLU Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine", "55106-9": "Active ingredients (in each 20 mL) MUCINEX FAST-MAX DM MAX Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Active ingredients (in each 20 mL) MUCINEX NIGHTTIME COLD & FLU Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine", "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 12 mg (Fast-Max DM Max only) and sodium 16 mg (Nightshift Cold & Flu only) store at 20-25°C (68-77°F) do not refrigerate", "MUCINEX FAST-MAX DM MAX": "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 the impulse to cough to help you get to sleep", "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) 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 DM Max 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) glaucoma (Nightshift Cold & Flu only) trouble urinating due to an enlarged prostate gland (Nightshift Cold & Flu only) 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 72854-165-26 Mucinex® FAST-MAX ® DM MAX Dextromethorphan HBr – Cough Suppressant Guaifenesin – Expectorant Controls Cough Relieves Chest Congestion Thins & Loosens Mucus 4 Hour Dosing 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", "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.", "Inactive ingredients (MUCINEX FAST-MAX DM MAX)": "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", "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 NIGHTSHIFT COLD & FLU)": "ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:41.579308 · Updated: 2026-03-14T23:09:36.432892