drug facts

drug facts

SPL v5

SPL

SPL Set ID a1e8ad0f-a61f-488a-83f3-75a7fe1ae17d

Route

oral

Published

Effective Date 2023-10-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

dextromethorphan (20 mg) acetaminophen (650 mg) guaifenesin (400 mg) phenylephrine (10 mg)

Inactive Ingredients

anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin propyl gallate propylene glycol water sodium benzoate trisodium citrate dihydrate sorbitol sucralose xanthan gum

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2015-07-31

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Medication Information

Warnings

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

more than 6 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks everyday 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.

Uses

temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- sinus congestion and pressure
- sore throat
- minor aches and pains
- cough due to minor throat and bronchial irritation
temporarily reduces fever
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Directions

do not take more than directed (see overdose warning)
do not take more than 6 doses in any 24-hour period
measue only with dosing cup provided. Do not use any other dosing device.
dose as follows or as directed by a doctor
mL = milliliter
adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
children under 12 years of age: do not use

Other Information

each 20 mL contains: sodium12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, disodium EDTA,, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Principal Display Panel

COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX COLD, FLU & SORE THROAT ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief

Cold, Flu & Sore Throat

ACETAMINOPHEN 650 mg PAIN RELIEVER • FEVER REDUCER

DEXTROMETHORPHAN HBr 20 mg • COUGH SUPPRESSANT

GUAIFENESIN 400 mg • EXPECTORANT

PHENYLEPHRINE HCI 10 mg • NASAL DECONGESTANT

MULTI-SYMPTOM RELIEF

Relieves Headache & Fever
Controls Cough
Relieves Nasal & Chest Congestion
thins & loosens Mucus

FOR AGES 12 +

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, Distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore throat.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

www.topcarebrand.com

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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.
for children under 12 years of age
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.

Package Label

TOPCARE HEALTH Maximum Strength Cold, Flu & Sore Throat

Questions Or Comments?

Call toll free 1-888-423-0139

When Using This Product,

do not use more than directed.

Stop Use and Ask A Doctor If

redness or swelling is present
nervousness, dizziness or sleeplessness occur
new symptoms occur
pain, nasal congestion or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
cough comes back, or occurs with rash or persistent headache

These could be signs of a serious condition.

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.

Active Ingredients (in Each 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have

diabetes
liver disease
heart disease
thyroid disease
high blood pressure
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm (mucus)
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Warnings

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

more than 6 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks everyday 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.

Uses

temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- sinus congestion and pressure
- sore throat
- minor aches and pains
- cough due to minor throat and bronchial irritation
temporarily reduces fever
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Directions

do not take more than directed (see overdose warning)
do not take more than 6 doses in any 24-hour period
measue only with dosing cup provided. Do not use any other dosing device.
dose as follows or as directed by a doctor
mL = milliliter
adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
children under 12 years of age: do not use

Other Information (Other information)

each 20 mL contains: sodium12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

Principal Display Panel

COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX COLD, FLU & SORE THROAT ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief

Cold, Flu & Sore Throat

ACETAMINOPHEN 650 mg PAIN RELIEVER • FEVER REDUCER

DEXTROMETHORPHAN HBr 20 mg • COUGH SUPPRESSANT

GUAIFENESIN 400 mg • EXPECTORANT

PHENYLEPHRINE HCI 10 mg • NASAL DECONGESTANT

MULTI-SYMPTOM RELIEF

Relieves Headache & Fever
Controls Cough
Relieves Nasal & Chest Congestion
thins & loosens Mucus

FOR AGES 12 +

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, Distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore throat.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]

www.topcarebrand.com

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Do Not Use (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.
for children under 12 years of age
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.

Package Label

TOPCARE HEALTH Maximum Strength Cold, Flu & Sore Throat

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-423-0139

When Using This Product, (When using this product,)

do not use more than directed.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

redness or swelling is present
nervousness, dizziness or sleeplessness occur
new symptoms occur
pain, nasal congestion or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
cough comes back, or occurs with rash or persistent headache

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

diabetes
liver disease
heart disease
thyroid disease
high blood pressure
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm (mucus)
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold and flu symptoms: nasal congestion headache sinus congestion and pressure sore throat minor aches and pains cough due to minor throat and bronchial irritation temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "Purposes": "Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks everyday 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 6 doses in any 24-hour period measue only with dosing cup provided. Do not use any other dosing device. dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use", "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. for children under 12 years of age 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.", "Package Label": "TOPCARE HEALTH Maximum Strength Cold, Flu & Sore Throat", "Other information": "each 20 mL contains: sodium12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.", "Inactive ingredients": "anhydrous citric acid, disodium EDTA,, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum", "Questions or comments?": "Call toll free 1-888-423-0139", "Principal Display Panel": "COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX COLD, FLU & SORE THROAT ACTIVE INGREDIENTS* MAXIMUM STRENGTH Mucus Relief Cold, Flu & Sore Throat ACETAMINOPHEN 650 mg PAIN RELIEVER • FEVER REDUCER DEXTROMETHORPHAN HBr 20 mg • COUGH SUPPRESSANT GUAIFENESIN 400 mg • EXPECTORANT PHENYLEPHRINE HCI 10 mg • NASAL DECONGESTANT MULTI-SYMPTOM RELIEF Relieves Headache & Fever Controls Cough Relieves Nasal & Chest Congestion thins & loosens Mucus FOR AGES 12 + FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, Distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore throat. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 topcare@topco.com www.topcarebrand.com", "When using this product,": "do not use more than directed.", "Stop use and ask a doctor if": "redness or swelling is present nervousness, dizziness or sleeplessness occur new symptoms occur pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days cough comes back, or occurs with rash or persistent headache These could be signs of a serious condition.", "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.", "Active ingredients (in each 20 mL)": "Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "diabetes liver disease heart disease thyroid disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": " taking the blood thinning drug warfarin."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:23.704981 · Updated: 2026-03-14T23:01:24.251815