Mucinex® Rapid Clear® Day Night Caplet + Clear & Cool Nasal Spray Combo

Mucinex® Rapid Clear® Day Night Caplet + Clear & Cool Nasal Spray Combo
SPL v1
SPL
SPL Set ID 37dcb0ed-df56-1bec-e063-6394a90a695e
Routes
ORAL NASAL
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) Triprolidine (1.25 mg) Dextromethorphan (10 mg) Oxymetazoline (0.05 g)
Inactive Ingredients
Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Polyethylene Glycol, Unspecified Titanium Dioxide Polyvinyl Alcohol Povidone Croscarmellose Sodium Talc Magnesium Stearate Microcrystalline Cellulose Crospovidone, Unspecified Polysorbate 80 Hypromellose, Unspecified Camphor (natural) Benzalkonium Chloride Benzododecinium Chloride

Identifiers & Packaging

Pill Appearance
Imprint: VVV;LOGOcrescentmoonplus Shape: oval Color: red Color: yellow Size: 20 mm Size: 19 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 Triprolidine HCl 1.25 mg SPRAY Oxymetazoline hydrochloride 0.05%


Medication Information

Warnings and Precautions

DAY

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.

NIGHT

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

■ more than 8 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 ■ 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 amotor vehicle or operatingmachinery

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.

SPRAY

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage

do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen

this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge

the use of this container by more than one person may spread infection

Stop use and ask a doctor ifsymptoms persist

If pregnant or breast-feeding,ask a health professional before use.

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

SPRAY

Uses

temporarily relieves nasal congestion due to:

  • a cold
  • hay fever or other upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes

Dosage and Administration

DAY

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

NIGHT

Directions

■ do not take more than directed (see Overdose warning)

■ do not take more than 8 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

SPRAY

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

children under 6 years of age: consult a doctor.

Shake well before use.



To open, hold by the white grips then squeeze, push down

firmly and turn cap counterclockwise. Before using for the

first time, remove the protective cap from the tip and prime

metered pump by depressing firmly several times. To spray,

hold bottle with thumb at the base and nozzle between first

and second fingers. Without tilting head, insert nozzle into

nostril. Fully depress pump all the way down with a firm

even stroke and sniff deeply. Wipe nozzle clean after use.

To close, turn cap clockwise.

DO NOT DISCARD CAP.

Description

DAY Acetaminophen 325 mg Guaifenesin 200 mg NIGHT Acetaminophen 325 mg Dextromethorphan HBr 10 mg Triprolidine HCl 1.25 mg SPRAY Oxymetazoline hydrochloride 0.05%

Section 50565-1

Keep out of reach of children.

If pregnant or breast-feeding,ask a health professional before use.

Section 51727-6

DAY

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

NIGHT

Inactive ingredients

croscarmellose sodium, crospovidone, hypromellose,

microcrystalline cellulose, polyethylene glycol,

polysorbate 80, povidone, titanium dioxide

SPRAY

benzalkonium chloride,

benzododecinium chloride,

camphor

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

Triprolidine HCl 1.25 mg...................................Antihistamine

SPRAY

Oxymetazoline hydrochloride 0.05% - Nasal decongestant

Section 55106-9

DAY

Acetaminophen 325 mg

Guaifenesin 200 mg

NIGHT

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Triprolidine HCl 1.25 mg

SPRAY

Oxymetazoline hydrochloride 0.05%

Section 60561-8

DAY/NIGHT/SPRAY

Other information

■ store at 20-25°C (68-77°F)


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

SPRAY

Uses

temporarily relieves nasal congestion due to:

  • a cold
  • hay fever or other upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes

Dosage and Administration (34068-7)

DAY

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

NIGHT

Directions

■ do not take more than directed (see Overdose warning)

■ do not take more than 8 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

SPRAY

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

children under 6 years of age: consult a doctor.

Shake well before use.



To open, hold by the white grips then squeeze, push down

firmly and turn cap counterclockwise. Before using for the

first time, remove the protective cap from the tip and prime

metered pump by depressing firmly several times. To spray,

hold bottle with thumb at the base and nozzle between first

and second fingers. Without tilting head, insert nozzle into

nostril. Fully depress pump all the way down with a firm

even stroke and sniff deeply. Wipe nozzle clean after use.

To close, turn cap clockwise.

DO NOT DISCARD CAP.

Warnings and Precautions (34071-1)

DAY

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.

NIGHT

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

■ more than 8 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 ■ 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 amotor vehicle or operatingmachinery

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.

SPRAY

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage

do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen

this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge

the use of this container by more than one person may spread infection

Stop use and ask a doctor ifsymptoms persist

If pregnant or breast-feeding,ask a health professional before use.

Section 50565-1 (50565-1)

Keep out of reach of children.

If pregnant or breast-feeding,ask a health professional before use.

Section 51727-6 (51727-6)

DAY

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

NIGHT

Inactive ingredients

croscarmellose sodium, crospovidone, hypromellose,

microcrystalline cellulose, polyethylene glycol,

polysorbate 80, povidone, titanium dioxide

SPRAY

benzalkonium chloride,

benzododecinium chloride,

camphor

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

Triprolidine HCl 1.25 mg...................................Antihistamine

SPRAY

Oxymetazoline hydrochloride 0.05% - Nasal decongestant

Section 55106-9 (55106-9)

DAY

Acetaminophen 325 mg

Guaifenesin 200 mg

NIGHT

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Triprolidine HCl 1.25 mg

SPRAY

Oxymetazoline hydrochloride 0.05%

Section 60561-8 (60561-8)

DAY/NIGHT/SPRAY

Other information

■ store at 20-25°C (68-77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)