Mucinex® Fast-max® Liquid Gels - Day Night Cold & Flu

Mucinex® Fast-max® Liquid Gels - Day Night Cold & Flu
SPL v1
SPL
SPL Set ID 3856c1e4-814f-85c4-e063-6394a90ab8a8
Route
ORAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Red No. 40 Gelatin Light Mineral Oil Mannitol Polyethylene Glycol 400 Povidone Water Hypromelloses Isopropyl Alcohol Propylene Glycol Sorbitol Fd&c Yellow No. 6 1,4-sorbitan Lecithin, Sunflower Titanium Dioxide Glycerin D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: AR18 Shape: oval Color: red Color: green Size: 24 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

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


Medication Information

Warnings and Precautions

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

Indications and Usage

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

Dosage and Administration

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

Description

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

Section 50565-1



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.

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions? 1-866-MUCINEX (1-866-682-4639)

Section 55105-1

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

Section 55106-9

Day:

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Night:

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Section 60561-8



Other information

■ store at 20-25°C (68-77°F)

■ avoid excessive heat


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)



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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-866-MUCINEX (1-866-682-4639)

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Day:

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Night:

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Section 60561-8 (60561-8)



Other information

■ store at 20-25°C (68-77°F)

■ avoid excessive heat


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