Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 22918db6-9096-4eb8-a742-aaa2dd5c31da
Route
ORAL
Published
Effective Date 2025-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Guaifenesin (200 mg) Doxylamine (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Yellow No. 6 Propylene Glycol Water Sodium Citrate Glycerin Saccharin Sodium Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum Fd&c Blue No. 1 Fd&c Red No. 40 Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-31

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

DAYTIME

  • 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
    • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

NIGHTTIME

  •   temporarily relieves these common cold/flu symptoms
    • nasal congestion
    • sore throat 
    • headache 
    • sinus congestion and pressure
    • minor aches and pains
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
  • temporarily reduces
    • fever
    • cough to help you sleep
    • swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
Warnings

DAYTIME

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

  • adult takes 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
  • 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.

NIGHTTIME

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:

  • 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

DAYTIME

  • take only as 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 any other dosing device.
  • keep dosing cup with product
  • mL= milliliter
adults and children 12 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 

 

  • When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

 

NIGHTTIME

  • take only as directed (see Overdose warning)
  • Do not exceed 4 doses per 24 hours
  • measure only with dosing cup provided. Do not use any other dosing device.   
  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 4 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing


Do Not Use

DAYTIME NIGHTTIME

  • 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Product Label
FAMILY WELLNESS Daytime Nighttime Cold & Flu Relief
Other Information

DAYTIME

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

NIGHTTIME

  • each 30 mL contains: sodium 64 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients

DayTime 

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

NightTime 

anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, trisodium citrate dehydrate, sorbitol, sucralose, xanthan gum

Purposes for Daytime

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Questions Or Comments?

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

Principal Display Panel

CCOMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® & NYQUIL® COLD & FLU*

DAYTIME

DAYTIME

COLD & FLU RELIEF

ACETAMINOPHEN 325 mg

Pain reliever / Fever reducer

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

Phenylephrine HCI 5 mg

Nasal decongestant

Relieves

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

Max strength

Alcohol free

For ages 6 years and over

NIGHTTIME

NIGHTTIME

COLD & FLU RELIEF

ACETAMINOPHEN 650 mg

Pain reliever / Fever reducer

Dextromethorphan HBr 20 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

Phenylephrine HCI 10 mg

Nasal decongestant

Relieves

  • Headache, fever, sore throat, minor aches & pains
  • Nasal/sinus congestion & sinus pressure
  • Sneezing
  • Runny nose
  • Cough

Max strength

Alcohol free

FL OZ (mL)

BERRY FLAVOR

When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing.

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

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320

When Using This Product

DAYTIME

do not take more than directed

NIGHTTIME

  • do not take more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If

DAYTIME

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
  • fever gets worse, or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition.

NIGHTTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion, 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 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.

DAYTIME NIGHTTIME

Overdose warning:Taking more than the recommended dose (overdose) may couse 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.

Ask A Doctor Before Use If the User Has

DAYTIME

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

NIGHTTIME

  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • glaucoma
  • a sodium-restricted diet
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
Active Ingredients  (in Each 15 Ml) Daytime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

DAYTIME

taking the blood thinning drug warfarin.

NIGHTTIME

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Active Ingredients for (in Each 30 Ml) Nighttime

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine Succinate 12.5 mg

Phenylephrine HCI 10 mg


Structured Label Content

Uses

DAYTIME

  • 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
    • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

NIGHTTIME

  •   temporarily relieves these common cold/flu symptoms
    • nasal congestion
    • sore throat 
    • headache 
    • sinus congestion and pressure
    • minor aches and pains
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
  • temporarily reduces
    • fever
    • cough to help you sleep
    • swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
Warnings

DAYTIME

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

  • adult takes 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
  • 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.

NIGHTTIME

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:

  • 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

DAYTIME

  • take only as 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 any other dosing device.
  • keep dosing cup with product
  • mL= milliliter
adults and children 12 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 

 

  • When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

 

NIGHTTIME

  • take only as directed (see Overdose warning)
  • Do not exceed 4 doses per 24 hours
  • measure only with dosing cup provided. Do not use any other dosing device.   
  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 4 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing


Do Not Use (Do not use)

DAYTIME NIGHTTIME

  • 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Product Label
FAMILY WELLNESS Daytime Nighttime Cold & Flu Relief
Other Information (Other information)

DAYTIME

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

NIGHTTIME

  • each 30 mL contains: sodium 64 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients (Inactive ingredients)

DayTime 

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

NightTime 

anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, trisodium citrate dehydrate, sorbitol, sucralose, xanthan gum

Purposes for Daytime (Purposes for DayTime)

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purpose for Nighttime (Purpose for NightTime)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

CCOMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® & NYQUIL® COLD & FLU*

DAYTIME

DAYTIME

COLD & FLU RELIEF

ACETAMINOPHEN 325 mg

Pain reliever / Fever reducer

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

Phenylephrine HCI 5 mg

Nasal decongestant

Relieves

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

Max strength

Alcohol free

For ages 6 years and over

NIGHTTIME

NIGHTTIME

COLD & FLU RELIEF

ACETAMINOPHEN 650 mg

Pain reliever / Fever reducer

Dextromethorphan HBr 20 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

Phenylephrine HCI 10 mg

Nasal decongestant

Relieves

  • Headache, fever, sore throat, minor aches & pains
  • Nasal/sinus congestion & sinus pressure
  • Sneezing
  • Runny nose
  • Cough

Max strength

Alcohol free

FL OZ (mL)

BERRY FLAVOR

When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing.

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

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320

When Using This Product (When using this product)

DAYTIME

do not take more than directed

NIGHTTIME

  • do not take more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

DAYTIME

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
  • fever gets worse, or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition.

NIGHTTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion, 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 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.)

DAYTIME NIGHTTIME

Overdose warning:Taking more than the recommended dose (overdose) may couse 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.

Ask A Doctor Before Use If the User Has (Ask a doctor before use if the user has)

DAYTIME

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

NIGHTTIME

  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • glaucoma
  • a sodium-restricted diet
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
Active Ingredients  (in Each 15 Ml) Daytime (Active ingredients  (in each 15 mL) DAYTIME)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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

DAYTIME

taking the blood thinning drug warfarin.

NIGHTTIME

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Active Ingredients for (in Each 30 Ml) Nighttime (Active ingredients for (in each 30 mL) NIGHTTIME)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine Succinate 12.5 mg

Phenylephrine HCI 10 mg


Advanced Ingredient Data


Raw Label Data

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