Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID 6c952c81-c8b6-4e74-abd8-781f6f44736b

Route

ORAL

Published

Effective Date 2024-05-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Disodium Edta-copper Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-06-30

Description

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

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Medication Information

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

Uses

temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- sinus congestion and pressure
- sore throat
- cough due to minor throat and bronchial irritation
- minor aches and pains
- 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 4,000 mg of acetaminophen in 24 hours
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.

Directions

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

Do Not Use

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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Package Label

SIGNATURE CARE Maximum Strength Cold, Flu & Sore Throat Relief

Other Information

each 20 mL contains: sodium 12 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?

Call1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

AGES 12 & OVER

Maximum Strength

Cold, Flu & Sore Throat Relief

Acetaminophen 650 mg

-Pain Reliever - Fever Reducer

Dextromethorphan HBr 20 mg

-Cough Suppressant

Guaifenesin 400 mg

-Expectorant

Phenylephrine HCl 10 mg

-Nasal Decongestant

Relief of: fever, aches, cough, stuffy nose, mucus & chest congestion

Compare to Maximum strength Mucinex®Fast-Max® Cold, Flu & Sore Throat active ingredients*

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

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.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 headache that lasts

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 (1-800-222-1222) 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

Uses

temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- sinus congestion and pressure
- sore throat
- cough due to minor throat and bronchial irritation
- minor aches and pains
- 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 4,000 mg of acetaminophen in 24 hours
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.

Directions

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

Do Not Use (Do not use)

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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Package Label

SIGNATURE CARE Maximum Strength Cold, Flu & Sore Throat Relief

Other Information (Other information)

each 20 mL contains: sodium 12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients (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? (Questions or comments?)

Call1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

AGES 12 & OVER

Maximum Strength

Cold, Flu & Sore Throat Relief

Acetaminophen 650 mg

-Pain Reliever - Fever Reducer

Dextromethorphan HBr 20 mg

-Cough Suppressant

Guaifenesin 400 mg

-Expectorant

Phenylephrine HCl 10 mg

-Nasal Decongestant

Relief of: fever, aches, cough, stuffy nose, mucus & chest congestion

Compare to Maximum strength Mucinex®Fast-Max® Cold, Flu & Sore Throat active ingredients*

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

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

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 headache that lasts

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 cough due to minor throat and bronchial irritation minor aches and pains 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 4,000 mg of acetaminophen in 24 hours 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.", "Directions": "do not take more than directed (see overdose warning) do not take more than 6 doses in a 24-hour period measure only with dosing cup provided.Do not use any other dosing device. keep dosing cup with product dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and older: 20 mL every 4 hours while symptoms last children under 12 years of age: do not use", "Do not use": "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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.", "Package Label": "SIGNATURE CARE Maximum Strength Cold, Flu & Sore Throat Relief", "Other information": "each 20 mL contains: sodium 12 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?": " Cal l1-888-723-3929 Monday-Friday 7AM-6PM PST", "Principal Display Panel": "AGES 12 & OVER Maximum Strength Cold, Flu & Sore Throat Relief Acetaminophen 650 mg -Pain Reliever - Fever Reducer Dextromethorphan HBr 20 mg -Cough Suppressant Guaifenesin 400 mg -Expectorant Phenylephrine HCl 10 mg -Nasal Decongestant Relief of: fever, aches, cough, stuffy nose, mucus & chest congestion Compare to Maximum strength Mucinex®Fast-Max® Cold, Flu & Sore Throat active ingredients* 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 BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 www.betterlivingbrandsLLC.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 headache that lasts 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 (1-800-222-1222) 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: 2026-02-15T12:03:04.955841 · Updated: 2026-03-14T23:02:57.214195