Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID a99fdd49-0160-4a82-983b-fa56ab38ae76
Route
ORAL
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum Acesulfame Potassium Alcohol D&c Yellow No. 10 Fd&c Green No. 3 Trisodium Citrate Dihydrate High Fructose Corn Syrup Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-07-30 Until 2027-02-28
Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

DAYTIME

  • temporarily relieves common cold and flu symptoms 
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion 
    • fever
    • cough due to minor throat and bronchial irritation

NIGHTTIME

  •   temporarily relieves common cold/flu symptoms 
    • minor aches and pain
    • headache
    • sore throat
    • runny nose  and sneezing
    • fever
    • cough due to minor throat and bronchial irritations as may occur with a cold
Warnings

DAYTIME NIGHTTIME

Liver warning: This product contain 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.

Directions

DAYTIME

  • do not take more than 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
 adult 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 

NIGHTTIME

  •   do not take more than 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
  • adult and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: 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 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 contain an MAOI, ask a doctor or pharmacist before taking this product
Product Label
WALGREENS Daytime Nighttime Cold and Flu
Other Information

DAYTIME

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

NIGHTTIME

  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains: sodium 19 mL
  • 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, xanthan gum

NIGHTTIME

acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow #10 FD&C green #3, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, trisodium citrate dihydrate

Purposes for Day Time

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredients in Vick® Dayquil® Cold & Flu & Vick® Nyquil® Cold & Flu††

DAYTIME • NON-DROWSY

Cold & Cough

ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr 10 mg  / COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

Multi-Symptom

  • Relieves aches, fever,& sore throat, cough & nasal congestion

  • For ages 6 years & over

  • Alcohol free
  • Antihistamine free

FL OZ (mL)

NIGHTTIME

Cold & Flu

ACETAMINOPHEN 650 mg / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr 30 mg / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE 12.5 mg / ANTIHISTAMINE

Multi-Symptom

  • Relieves headache, fever, sore throat, minor aches & pains, sneezing, runny nose & cough
  • For ages 12 years & over
  • Nighttime relief

  • ALCOHOL 10%

FL OZ (mL)

WHEN USING OTHER DAYTIME OR NIGHTTIME PRODUCTS, CAREFULLY READ EACH LABEL TO ENSURE CORRECT DOSING

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

††These products are not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and Nyquil® are registered trademarks of the Procter & Gamble Company.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015  walgreens.com

When Using This Product

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

  • excitability may occur, especially in children
  • mark 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

NIGHTTIME

  • pain or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • 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 adult as  well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Have

DAYTIME

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

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active Ingredients for (in Each 30 Ml) Nighttime

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Or Pharmacist Before Use If the Child Is

DAYTIME

if you are taking the blood thinning drug warfarin

NIGHTTIME

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

DAYTIME

  • temporarily relieves common cold and flu symptoms 
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion 
    • fever
    • cough due to minor throat and bronchial irritation

NIGHTTIME

  •   temporarily relieves common cold/flu symptoms 
    • minor aches and pain
    • headache
    • sore throat
    • runny nose  and sneezing
    • fever
    • cough due to minor throat and bronchial irritations as may occur with a cold
Warnings

DAYTIME NIGHTTIME

Liver warning: This product contain 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.

Directions

DAYTIME

  • do not take more than 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
 adult 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 

NIGHTTIME

  •   do not take more than 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
  • adult and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use


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 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 contain an MAOI, ask a doctor or pharmacist before taking this product
Product Label
WALGREENS Daytime Nighttime Cold and Flu
Other Information (Other information)

DAYTIME

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

NIGHTTIME

  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains: sodium 19 mL
  • 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, xanthan gum

NIGHTTIME

acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow #10 FD&C green #3, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, trisodium citrate dihydrate

Purposes for Day Time

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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 Vick® Dayquil® Cold & Flu & Vick® Nyquil® Cold & Flu††

DAYTIME • NON-DROWSY

Cold & Cough

ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr 10 mg  / COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

Multi-Symptom

  • Relieves aches, fever,& sore throat, cough & nasal congestion

  • For ages 6 years & over

  • Alcohol free
  • Antihistamine free

FL OZ (mL)

NIGHTTIME

Cold & Flu

ACETAMINOPHEN 650 mg / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr 30 mg / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE 12.5 mg / ANTIHISTAMINE

Multi-Symptom

  • Relieves headache, fever, sore throat, minor aches & pains, sneezing, runny nose & cough
  • For ages 12 years & over
  • Nighttime relief

  • ALCOHOL 10%

FL OZ (mL)

WHEN USING OTHER DAYTIME OR NIGHTTIME PRODUCTS, CAREFULLY READ EACH LABEL TO ENSURE CORRECT DOSING

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

††These products are not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and Nyquil® are registered trademarks of the Procter & Gamble Company.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015  walgreens.com

When Using This Product (When using this product)

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

  • excitability may occur, especially in children
  • mark 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

NIGHTTIME

  • pain or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • 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.)

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 adult as  well as for children even if you do not notice any signs or symptoms.

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

DAYTIME

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

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active Ingredients for (in Each 30 Ml) Nighttime (Active ingredients for (in each 30 mL) Nighttime)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

DAYTIME

if you are taking the blood thinning drug warfarin

NIGHTTIME

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:57.396321 · Updated: 2026-03-14T23:10:03.511025