Mucinex® Fast-max® Liquid Gels - Cold, Flu & Sore Throat

Mucinex® Fast-max® Liquid Gels - Cold, Flu & Sore Throat
SPL v4
SPL
SPL Set ID 37ded76a-ee8d-f22c-e063-6394a90a00c2
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) Guaifenesin (200 mg)
Inactive Ingredients
Lecithin, Soybean Glycerin Sorbitol Solution Water Hypromellose, Unspecified Gelatin, Unspecified Propylene Glycol Titanium Dioxide Light Mineral Oil Polyethylene Glycol, Unspecified Povidone, Unspecified Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: AR09 Shape: oval Color: blue Size: 23 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 43683-2

■ 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

Section 50565-1

Keep out of reach of children.

Section 55106-9

Acetaminophen 325 mg.............Pain reliever/fever reducer

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

Warnings

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

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.

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

Questions?

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

Other Information

■ store at 20-25°C (68-77°F)

■ avoid excessive heat

Inactive Ingredients

FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light

mineral oil, polyethylene glycol, povidone, propylene glycol,

purified water, sorbitol sorbitan solution, titanium dioxide

Principal Display Panel

Fast Dissolving Liquid Gels!

NDC 72854-164

Mucinex®

COLD, FLU, and SORE THROAT

Acetaminophen – Pain Reliever/Fever Reducer

Guaifenesin – Expectorant

✓Thins & Loosens Mucus

✓Relieves Sore Throat, Headache, and Body Pain

✓Reduces Fever



LIQUID GELS

(Liquid Filled Capsules)

Actual Size

DAY TIME

FOR AGES 12+


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

■ 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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55106-9 (55106-9)

Acetaminophen 325 mg.............Pain reliever/fever reducer

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

Warnings

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

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.

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

Questions?

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

Other Information

■ store at 20-25°C (68-77°F)

■ avoid excessive heat

Inactive Ingredients

FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light

mineral oil, polyethylene glycol, povidone, propylene glycol,

purified water, sorbitol sorbitan solution, titanium dioxide

Principal Display Panel

Fast Dissolving Liquid Gels!

NDC 72854-164

Mucinex®

COLD, FLU, and SORE THROAT

Acetaminophen – Pain Reliever/Fever Reducer

Guaifenesin – Expectorant

✓Thins & Loosens Mucus

✓Relieves Sore Throat, Headache, and Body Pain

✓Reduces Fever



LIQUID GELS

(Liquid Filled Capsules)

Actual Size

DAY TIME

FOR AGES 12+


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)