Family Wellness 44-005

SPL v4

SPL

SPL Set ID 9ac649db-5083-427c-9637-1e2aecd2ca44

Route

ORAL

Published

Effective Date 2026-01-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sodium Metabisulfite Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-06-28

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:
- headache
- stuffy nose
- cough
- minor aches and pains
- sore throat
- sinus congestion and pressure
- nasal congestion
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
temporarily reduces fever

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 every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

rash
blisters
skin reddening

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
do not take more than 6 doses in any 24-hour period
mL = milliliter
only use the dose cup provided
dose as follows or as directed by a doctor
adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
children under 12 years: 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.
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.

Other Information

each 20 mL contains: sodium 10 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Questions Or Comments?

1-800-426-9391

Principal Display Panel

FAMILY

Wellness™

COMPARE TO THE

ACTIVE INGREDIENTS IN

MAXIMUM STRENGTH

MUCINEX® FAST-MAX®

COLD, FLU & SORE THROAT*

MAXIMUM STRENGTH

COLD, FLU &

SORE THROAT

Acetaminophen

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Pain Reliever/Fever Reducer

Cough Suppressant

Expectorant

Nasal Decongestant

• Relieves body pain, headache,

fever & sore throat

• Controls cough

• Relieves nasal & chest congestion

• Thins & loosens mucus

• Relieves sinus pressure & congestion

AGES

12 YEARS

& OVER

MIXED BERRY

FLAVORED

NDC 55319-705-45

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

*This product is not manufactured or distributed by RB Health (US) LLC, owner

of the registered trademark Maximum Strength Mucinex® FAST-MAX® Cold, Flu

& Sore Throat. 50844 REV0724A00545

DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to

the store of purchase for

a refund (with receipt)

or exchange.

Family Wellness 44-005

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
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.

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

cough that occurs with too much phlegm (mucus)
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
liver disease
diabetes
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
heart disease

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:
- headache
- stuffy nose
- cough
- minor aches and pains
- sore throat
- sinus congestion and pressure
- nasal congestion
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
temporarily reduces fever

Purpose

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 every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

rash
blisters
skin reddening

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
do not take more than 6 doses in any 24-hour period
mL = milliliter
only use the dose cup provided
dose as follows or as directed by a doctor
adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
children under 12 years: do not use

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.
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.

Other Information (Other information)

each 20 mL contains: sodium 10 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

FAMILY

Wellness™

COMPARE TO THE

ACTIVE INGREDIENTS IN

MAXIMUM STRENGTH

MUCINEX® FAST-MAX®

COLD, FLU & SORE THROAT*

MAXIMUM STRENGTH

COLD, FLU &

SORE THROAT

Acetaminophen

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Pain Reliever/Fever Reducer

Cough Suppressant

Expectorant

Nasal Decongestant

• Relieves body pain, headache,

fever & sore throat

• Controls cough

• Relieves nasal & chest congestion

• Thins & loosens mucus

• Relieves sinus pressure & congestion

AGES

12 YEARS

& OVER

MIXED BERRY

FLAVORED

NDC 55319-705-45

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

*This product is not manufactured or distributed by RB Health (US) LLC, owner

of the registered trademark Maximum Strength Mucinex® FAST-MAX® Cold, Flu

& Sore Throat. 50844 REV0724A00545

DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to

the store of purchase for

a refund (with receipt)

or exchange.

Family Wellness 44-005

When Using This Product (When using this product)

do not exceed recommended dosage.

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

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
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)

cough that occurs with too much phlegm (mucus)
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
liver disease
diabetes
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
heart disease

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: headache stuffy nose cough minor aches and pains sore throat sinus congestion and pressure nasal congestion 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 temporarily reduces fever", "Purpose": "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 every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: rash blisters skin reddening 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 do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: 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. 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.", "Other information": "each 20 mL contains: sodium 10 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package", "Inactive ingredients": "anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose", "Questions or comments?": "1-800-426-9391", "Principal display panel": "FAMILY Wellness™ COMPARE TO THE ACTIVE INGREDIENTS IN MAXIMUM STRENGTH MUCINEX® FAST-MAX® COLD, FLU & SORE THROAT* MAXIMUM STRENGTH COLD, FLU & SORE THROAT Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl Pain Reliever/Fever Reducer Cough Suppressant Expectorant Nasal Decongestant • Relieves body pain, headache, fever & sore throat • Controls cough • Relieves nasal & chest congestion • Thins & loosens mucus • Relieves sinus pressure & congestion AGES 12 YEARS & OVER MIXED BERRY FLAVORED NDC 55319-705-45 6 FL OZ (177 mL) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org *This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX® Cold, Flu & Sore Throat. 50844 REV0724A00545 DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or exchange. Family Wellness 44-005", "When using this product": "do not exceed recommended dosage.", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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.": "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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": "cough that occurs with too much phlegm (mucus) thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland liver disease diabetes persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema heart disease", "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: 2026-02-15T12:08:08.236047 · Updated: 2026-03-14T23:12:17.704012