SPL v1
SPL
SPL Set ID 350764de-7801-b24e-e063-6394a90ab3c3
Route
ORAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Acetaminophen (325 mg)
Inactive Ingredients
Titanium Dioxide Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol Povidone, Unspecified Croscarmellose Sodium Magnesium Stearate Talc Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: VVV;MSC Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Guaifenesin 200 mg


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.



Ask a doctor before use if you have

■ liver disease

■ persistent or chronic cough such as occurs

with smoking, asthma, chronic bronchitis, 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.

Indications and Usage

Uses

■ temporarily relieves these common cold and flu

symptoms:

■ minor aches and pains ■ headache

■ sore throat

■ helps loosen phlegm (mucus) and thin

bronchial secretions to rid the bronchial

passageways of bothersome mucus and make

coughs more productive

■ temporarily reduces fever

Dosage and Administration

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

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Guaifenesin 200 mg

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, magnesium stearate, 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 325 mg ........ Pain reliever/

fever reducer

Guaifenesin 200 mg.................... Expectorant

Section 55106-9

Active ingredients

(in each caplet)



Acetaminophen 325 mg

Guaifenesin 200 mg

Section 60561-8

Other information

■ store at 20-25°C (68-77°F)


Structured Label Content

Indications and Usage (34067-9)

Uses

■ temporarily relieves these common cold and flu

symptoms:

■ minor aches and pains ■ headache

■ sore throat

■ helps loosen phlegm (mucus) and thin

bronchial secretions to rid the bronchial

passageways of bothersome mucus and make

coughs more productive

■ temporarily reduces fever

Dosage and Administration (34068-7)

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

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.



Ask a doctor before use if you have

■ liver disease

■ persistent or chronic cough such as occurs

with smoking, asthma, chronic bronchitis, 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 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, magnesium stearate, 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 325 mg ........ Pain reliever/

fever reducer

Guaifenesin 200 mg.................... Expectorant

Section 55106-9 (55106-9)

Active ingredients

(in each caplet)



Acetaminophen 325 mg

Guaifenesin 200 mg

Section 60561-8 (60561-8)

Other information

■ store at 20-25°C (68-77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)