Mucinex Fast-max Cold & Flu

Mucinex Fast-max Cold & Flu
SPL v1
SPL
SPL Set ID 31ac6883-ffcd-39de-e063-6294a90a52dd
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Aluminum Lake Titanium Dioxide Fd&c Red No. 40 Aluminum Lake Polyvinyl Alcohol Povidone Polyethylene Glycol, Unspecified Croscarmellose Sodium Microcrystalline Cellulose Talc

Identifiers & Packaging

Pill Appearance
Imprint: Chevron Shape: oval Color: red Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen.



Severe liver damage may occur if you take:

■ more than 12 caplets 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

If pregnant or breast-feeding, ask a health

professional before use.



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.

Description

Drug Facts

Uses

Uses

■ 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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

croscarmellose sodium, FD&C red no. 40 aluminum

lake, FD&C yellow no. 6 aluminum lake,

microcrystalline cellulose, polyethylene glycol,

polyvinyl alcohol, povidone, talc, titanium dioxide

Section 51945-4

Section 53413-1

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

Section 55105-1

Acetaminophen » Pain Reliever/Fever Reducer

Dextromethorphan HBr » Cough Suppressant

Section 55106-9

Acetaminophen 325 mg...Pain reliever/fever reducer

Dextromethorphan HBr 10 mg...Cough suppressant

Section 60561-8

Other information

■ store at 20-25°C (68-77°F)

Directions

Directions

■ do not take more than directed (see Overdose

warning)

■ do not take more than 12 caplets in any 24-hour

period

■ adults and children 12 years of age and over:

take 2 caplets every 4 hours

■ children under 12 years of age: do not use


Structured Label Content

Uses

Uses

■ 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

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen.



Severe liver damage may occur if you take:

■ more than 12 caplets 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

If pregnant or breast-feeding, ask a health

professional before use.



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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

croscarmellose sodium, FD&C red no. 40 aluminum

lake, FD&C yellow no. 6 aluminum lake,

microcrystalline cellulose, polyethylene glycol,

polyvinyl alcohol, povidone, talc, 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)

Acetaminophen » Pain Reliever/Fever Reducer

Dextromethorphan HBr » Cough Suppressant

Section 55106-9 (55106-9)

Acetaminophen 325 mg...Pain reliever/fever reducer

Dextromethorphan HBr 10 mg...Cough suppressant

Section 60561-8 (60561-8)

Other information

■ store at 20-25°C (68-77°F)

Directions

Directions

■ do not take more than directed (see Overdose

warning)

■ do not take more than 12 caplets in any 24-hour

period

■ adults and children 12 years of age and over:

take 2 caplets every 4 hours

■ children under 12 years of age: do not use


Advanced Ingredient Data


Raw Label Data

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