Mucinex Rapid+clear Nighttime Headache, Cough & Fever

Mucinex Rapid+clear Nighttime Headache, Cough & Fever
SPL v2
SPL
SPL Set ID 35322238-d498-1a52-e063-6394a90ac9c4
Route
ORAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Triprolidine (1.25 mg)
Inactive Ingredients
Hypromellose, Unspecified Titanium Dioxide Microcrystalline Cellulose Polyethylene Glycol, Unspecified Croscarmellose Sodium Povidone, Unspecified Polysorbate 80 Crospovidone, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: VVV;LOGOcrescentmoonplus Shape: oval Color: yellow Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Triprolidine HCl 1.25 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

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

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Triprolidine HCl 1.25 mg

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

croscarmellose sodium, crospovidone, hypromellose,

microcrystalline cellulose, polyethylene glycol,

polysorbate 80, povidone, 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

Dextromethorphan HBr 10 mg................Cough suppressant

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

Section 55106-9

Active ingredients

(in each caplet)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Triprolidine HCl 1.25 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:

■ 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)

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

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

croscarmellose sodium, crospovidone, hypromellose,

microcrystalline cellulose, polyethylene glycol,

polysorbate 80, povidone, 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

Dextromethorphan HBr 10 mg................Cough suppressant

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

Section 55106-9 (55106-9)

Active ingredients

(in each caplet)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Triprolidine HCl 1.25 mg

Section 60561-8 (60561-8)

Other information

■ store at 20-25°C (68-77°F)


Advanced Ingredient Data


Raw Label Data

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