Mucinex® Rapid Clear® Pain, Headache & Mucus Congestion And Nighttime Liquid Gels

Mucinex® Rapid Clear® Pain, Headache & Mucus Congestion And Nighttime Liquid Gels
SPL v3
SPL
SPL Set ID 38571853-992f-9998-e063-6394a90a8581
Route
ORAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Hypromelloses Povidone Gelatin Glycerin Water Titanium Dioxide Sorbitol Solution Lecithin, Sunflower Light Mineral Oil Propylene Glycol Polyethylene Glycol, Unspecified Fd&c Blue No. 1 D&c Yellow No. 10 Isopropyl Alcohol Polyethylene Glycol 400 1,4-sorbitan Sorbitol Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: AR17 Shape: oval Color: blue Color: green Size: 23 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Day: Acetaminophen 325 mg Guaifenesin 200 mg Night: Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg


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.



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.

Night:



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 ■ 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

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.

Indications and Usage

Day:

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

Night:



Uses

■ 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

Day: Acetaminophen 325 mg Guaifenesin 200 mg Night: Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

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:



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

Night:

Inactive ingredients

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

Day:



Acetaminophen 325 mg...Pain reliever/fever reducer

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

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

Guaifenesin 200 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:

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

Night:



Uses

■ 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.



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.

Night:



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 ■ 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

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.

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:



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

Night:

Inactive ingredients

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)

Day:



Acetaminophen 325 mg...Pain reliever/fever reducer

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

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

Guaifenesin 200 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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