Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 480d8ee3-79d4-48e2-8402-145639f5779b

Route

ORAL

Published

Effective Date 2023-01-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Sorbitol Saccharin Sodium Sodium Benzoate Sodium Chloride Sodium Citrate Xanthan Gum Sucralose Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Completed Since 2017-12-31 Until 2025-10-31

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 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 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves common cold and flu symptoms:
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- cough due to minor throat and bronchial irritation
- temporarily restores freer breathing through the nose
- promotes nasal and or sinus drainage
- helps loosen phlegn (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Warnings

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

adult take more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
child takes more than 4 doses (15 mL each) in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

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

skin reddening
blistere
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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

take only as directed (see overdose warning)
do not take more than 4 doses in 24 hours
measure only with dosing cup provided. Do not use any other dosing device
mL = milliliter
keep dosing cup with product
when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

adults and children12 years and over	30 mL every 4 hours
children 6 to under 12 years	15 mL every 4 hours
children 4 to under 6 years	ask a doctor
children under 4 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.

Product Label

FAMILY WELLNESS Max Strength Severe Cold & Flu Relief

Other Information

each 15 mL contains: sodium 12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate sodium chloride, sodium citrate, sorbitol sucralose, xanthan gum

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® SEVERE COLD & FLU*

MAX STRENGTH

Severe Cold & Flu Relief

Acetaminophen (Pain Reliever/Fever reducer)

Dextromethorphan HBr (Cough suppressant)

Guaifenesin (Expectorant)

Phenylephrine HCI (Nasal decongestant)

Multi-Symptom Relief of:

Headache, fever, sore throat, minor aches & pains
Nasal / sinus congestion & sinus pressure
Cough
Chest congestion

Alcohol Free

Non-Drowsy

For Ages 6 Years & Over

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

When Using This Product

do not take more than directed.

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
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.

Overdose warning: Taking more than the recommended dose can cause serious 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 and for children even if you do not notice any signs or symptoms

Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If User Is

taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves common cold and flu symptoms:
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- cough due to minor throat and bronchial irritation
- temporarily restores freer breathing through the nose
- promotes nasal and or sinus drainage
- helps loosen phlegn (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

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

adult take more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
child takes more than 4 doses (15 mL each) in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

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

skin reddening
blistere
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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

take only as directed (see overdose warning)
do not take more than 4 doses in 24 hours
measure only with dosing cup provided. Do not use any other dosing device
mL = milliliter
keep dosing cup with product
when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

adults and children12 years and over	30 mL every 4 hours
children 6 to under 12 years	15 mL every 4 hours
children 4 to under 6 years	ask a doctor
children under 4 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.

Product Label

FAMILY WELLNESS Max Strength Severe Cold & Flu Relief

Other Information (Other information)

each 15 mL contains: sodium 12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate sodium chloride, sodium citrate, sorbitol sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® SEVERE COLD & FLU*

MAX STRENGTH

Severe Cold & Flu Relief

Acetaminophen (Pain Reliever/Fever reducer)

Dextromethorphan HBr (Cough suppressant)

Guaifenesin (Expectorant)

Phenylephrine HCI (Nasal decongestant)

Multi-Symptom Relief of:

Headache, fever, sore throat, minor aches & pains
Nasal / sinus congestion & sinus pressure
Cough
Chest congestion

Alcohol Free

Non-Drowsy

For Ages 6 Years & Over

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

When Using This Product (When using this product)

do not take more than directed.

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 5 days (children) or 7 days (adults)
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 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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

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

Ask A Doctor Or Pharmacist Before Use If User Is (Ask a doctor or pharmacist before use if user is)

taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains headache fever sore throat reduces swelling of nasal passages cough due to minor throat and bronchial irritation temporarily restores freer breathing through the nose promotes nasal and or sinus drainage helps loosen phlegn (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive", "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 adult take more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blistere 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Directions": "take only as directed (see overdose warning) do not take more than 4 doses in 24 hours measure only with dosing cup provided. Do not use any other dosing device mL = milliliter keep dosing cup with product when using other Daytime or Nighttime products, carefully read each label to insure correct dosing adults and children12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 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.", "Product Label": "FAMILY WELLNESS Max Strength Severe Cold & Flu Relief", "Other information": "each 15 mL contains: sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.", "Inactive ingredients": "citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate sodium chloride, sodium citrate, sorbitol sucralose, xanthan gum", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® SEVERE COLD & FLU* MAX STRENGTH Severe Cold & Flu Relief Acetaminophen ( Pain Reliever/Fever reducer) Dextromethorphan HBr (Cough suppressant) Guaifenesin (Expectorant) Phenylephrine HCI (Nasal decongestant) Multi-Symptom Relief of: Headache, fever, sore throat, minor aches & pains Nasal / sinus congestion & sinus pressure Cough Chest congestion Alcohol Free Non-Drowsy For Ages 6 Years & Over *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINITED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 10611 MONROE RD., MATTHEWS, NC 28105", "When using this product": "do not take more than directed.", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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.": "Overdose warning: Taking more than the recommended dose can cause serious 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 and for children even if you do not notice any signs or symptoms", "Active ingredients (in each 15 mL)": "Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema a sodium restricted diet", "Ask a doctor or pharmacist before use if user is": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:30.000976 · Updated: 2026-03-14T23:00:57.322924