SPL v1
SPL
SPL Set ID 34fd2458-9acd-cdf7-e063-6394a90a3d0a
Route
ORAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Triprolidine (2.5 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Fd&c Blue No. 1 Ammonium Glycyrrhizate Fd&c Red No. 40 Water Sorbitol Edetate Disodium Sodium Benzoate Glycerin Anhydrous Citric Acid Sucralose Xanthan Gum Propylene Glycol D&c Yellow No. 10 Trisodium Citrate Dihydrate

Identifiers & Packaging

Pill Appearance
Color: blue Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-02

Description

Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Acetaminophen 650 mg Dextromethorphan HBr 20 mg Triprolidine HCl 2.5 mg


Medication Information

Warnings and Precautions

Do not use

■ 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

■ persistent or chronic cough such as occurs

with smoking, asthma, chronic bronchitis, or

emphysema

■ cough that occurs with too much phlegm (mucus)

When using this product do not use more

than directed



Stop use and ask a doctor if

■ cough lasts more than 7 days, comes back, or

occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

you take:

■ more than 4,000 mg 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.

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 fever,

rash, or headache that lasts. These

could be signs of a serious condition.

Indications and Usage

Uses



■ helps loosen phlegm (mucus) and thin

bronchial secretions to rid the bronchial

passageways of bothersome mucus and

make coughs more productive

■ temporarily relieves:

■ cough due to minor throat and

bronchial irritation as may occur with

the common cold or inhaled irritants

■ the intensity of coughing

■ the impulse to cough to help you get

to sleep

■ 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 6 doses in any

24-hour period

■ measure only with dosing cup provided

■ do not use dosing cup with other products

■ dose as follows or as directed by a doctor

■ adults and children 12 years of age and over:

20 mL in dosing cup provided every 4 hours

■ children under 12 years of age: do not use

Directions

■ do not take more than directed (see

Overdose warning)

■ do not take more than 4 doses in any

24-hour period

■ measure only with dosing cup provided

■ do not use dosing cup with other products

■ dose as follows or as directed by a doctor

■ adults and children 12 years of age

and over: 20 mL in dosing cup provided

every 4 hours

■ children under 12 years of age: do not use

Description

Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Acetaminophen 650 mg Dextromethorphan HBr 20 mg Triprolidine HCl 2.5 mg

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

ammonium, glycyrrhizate, anhydrous citric acid, D&C yellow

no. 10, edetate disodium, FD&C blue no. 1, flavor,

glycerin (soy), propylene glycol, purified water,

sodium benzoate, sorbitol, sucralose, trisodium

citrate dihydrate*, xanthan gum

*may contain this ingredient

Inactive ingredients ammonium

glycyrrhizate, anhydrous citric acid, edetate

disodium, FD&C blue no. 1, FD&C red no.

40, flavor, glycerin (soy), propylene glycol,

purified water, sodium benzoate, sorbitol,

sucralose, xanthan gum

Section 51945-4

Section 53413-1

Questions?

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

Section 55105-1

Dextromethorphan HBr » Cough Suppressant

Guaifenesin » Expectorant

Acetaminophen » Pain reliever/fever reducer

Dextromethorphan » Cough suppressant

Triprolidine HCl » Antihistamine

Section 55106-9

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Triprolidine HCl 2.5 mg

Section 60561-8

Other information

■ each 20 mL contains: sodium 9 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate

Other information

■ each 20 mL contains: sodium 16 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate


Structured Label Content

Indications and Usage (34067-9)

Uses



■ helps loosen phlegm (mucus) and thin

bronchial secretions to rid the bronchial

passageways of bothersome mucus and

make coughs more productive

■ temporarily relieves:

■ cough due to minor throat and

bronchial irritation as may occur with

the common cold or inhaled irritants

■ the intensity of coughing

■ the impulse to cough to help you get

to sleep

■ 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 6 doses in any

24-hour period

■ measure only with dosing cup provided

■ do not use dosing cup with other products

■ dose as follows or as directed by a doctor

■ adults and children 12 years of age and over:

20 mL in dosing cup provided every 4 hours

■ children under 12 years of age: do not use

Directions

■ do not take more than directed (see

Overdose warning)

■ do not take more than 4 doses in any

24-hour period

■ measure only with dosing cup provided

■ do not use dosing cup with other products

■ dose as follows or as directed by a doctor

■ adults and children 12 years of age

and over: 20 mL in dosing cup provided

every 4 hours

■ children under 12 years of age: do not use

Warnings and Precautions (34071-1)

Do not use

■ 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

■ persistent or chronic cough such as occurs

with smoking, asthma, chronic bronchitis, or

emphysema

■ cough that occurs with too much phlegm (mucus)

When using this product do not use more

than directed



Stop use and ask a doctor if

■ cough lasts more than 7 days, comes back, or

occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

you take:

■ more than 4,000 mg 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.

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 fever,

rash, or headache that lasts. These

could be signs of a serious condition.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

ammonium, glycyrrhizate, anhydrous citric acid, D&C yellow

no. 10, edetate disodium, FD&C blue no. 1, flavor,

glycerin (soy), propylene glycol, purified water,

sodium benzoate, sorbitol, sucralose, trisodium

citrate dihydrate*, xanthan gum

*may contain this ingredient

Inactive ingredients ammonium

glycyrrhizate, anhydrous citric acid, edetate

disodium, FD&C blue no. 1, FD&C red no.

40, flavor, glycerin (soy), propylene glycol,

purified water, sodium benzoate, sorbitol,

sucralose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

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

Section 55105-1 (55105-1)

Dextromethorphan HBr » Cough Suppressant

Guaifenesin » Expectorant

Acetaminophen » Pain reliever/fever reducer

Dextromethorphan » Cough suppressant

Triprolidine HCl » Antihistamine

Section 55106-9 (55106-9)

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Triprolidine HCl 2.5 mg

Section 60561-8 (60561-8)

Other information

■ each 20 mL contains: sodium 9 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate

Other information

■ each 20 mL contains: sodium 16 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate


Advanced Ingredient Data


Raw Label Data

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