Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 3b4b3b04-eff9-4e06-8b37-f6729671d07f
Route
ORAL
Published
Effective Date 2023-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Acetaminophen (650 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Propylene Glycol Water Fd&c Red No. 40 Anhydrous Citric Acid Edetate Calcium Disodium Sodium Benzoate Trisodium Citrate Dihydrate Glycerin Propyl Gallate Sorbitol Sucralose Xanthan Gum Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-31
Description

Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 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 Diphenhydramine HCI 25 mg Phenylephrine HCI 10 mg 

Uses

Nighttime

  • temporarily relieves these common cold and flu symptoms
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep

Daytime

  • temporarily relieves these common cold and flu symptoms
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
Warnings

NIGHTTIME and DAYTIME

 Liver warning: This product contain 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

Nighttime

  • do not take more than directed (see overdose warning)
  • do not take more than 6 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 = mililiter
  • dose as follows or as directed by a doctor
  • adults and children 12 years and older: 20 mL every 4 hours while symptoms last
  • children under 12 years of age: do not use

Daytime

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


Do Not Use

Nighttime

  • with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine, even one used on the skin
  • 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
  • for children under 12 years of age

Daytime

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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
WALGREENS Night Time Cold & Flu Maximum Strength, Day Time Severe Cold Maximum Strength
Other Information

Nighttime

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

Daytime

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

Pain reliever / fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Inactive Ingredients

Nighttime

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

Daytime

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

Purpose for Nighttime

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Questions Or Comments?

Nighttime and DayTime

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

Principal Display Panel

NIGHTTIME

Compare to Maximum Strength Mucinex®Fast-Max® Severe Cold & Night Time Cold & Flu active ingredients††

NIGHTTIME

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER

DIPHENHYDRAMINE HCI / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves aches, fever, sore throat, nasal congestion, runny nose & sneezing
  • Controls cough  
  • For ages 12 & over

DAYTIME

DAYTIME

Severe Cold

ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves aches, fever & sore throat
  • Controls Cough
  • Clear nasal & chest congestion 
  • Thins & loosens mucus 
  • For ages 12 & over

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

↑↑This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Severe Cold & Nighttime Cold & Flu.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using These Products

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicile or operating machinery

Daytime

  • do not use more than directed
Stop Use and Ask A Doctor If

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or last 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 a signs of a serious condition

 Daytime

  • nervousness, dizziness or sleeplessness occur
  • pain, 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,

Nighttime and DayTime

ask a health professional before use.

Keep Out of Reach of Children.

Nighttime and DayTime

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.

Ask A Doctor Before Use If You Have

Nighttime

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

Daytime

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients for Daytime (in Each 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifeenesin 400 mg

Phenylephrine HCl 10 mg

Active Ingredients for Nighttime (in Each 20 Ml)

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg 

Ask A Doctor Or Pharmacist Before Use If You Are

Nighttime

  • you are taking the blood thinning drug warfarin
  • you are taking sedative or tranquilizers

Daytime

  • taking the blood thinning drug warfarin

Structured Label Content

Uses

Nighttime

  • temporarily relieves these common cold and flu symptoms
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep

Daytime

  • temporarily relieves these common cold and flu symptoms
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
Warnings

NIGHTTIME and DAYTIME

 Liver warning: This product contain 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

Nighttime

  • do not take more than directed (see overdose warning)
  • do not take more than 6 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 = mililiter
  • dose as follows or as directed by a doctor
  • adults and children 12 years and older: 20 mL every 4 hours while symptoms last
  • children under 12 years of age: do not use

Daytime

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


Do Not Use (Do not use)

Nighttime

  • with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine, even one used on the skin
  • 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
  • for children under 12 years of age

Daytime

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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
WALGREENS Night Time Cold & Flu Maximum Strength, Day Time Severe Cold Maximum Strength
Other Information (Other information)

Nighttime

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

Daytime

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

Pain reliever / fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Inactive Ingredients (Inactive ingredients)

Nighttime

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

Daytime

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

Purpose for Nighttime

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Questions Or Comments? (Questions or comments?)

Nighttime and DayTime

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

Principal Display Panel

NIGHTTIME

Compare to Maximum Strength Mucinex®Fast-Max® Severe Cold & Night Time Cold & Flu active ingredients††

NIGHTTIME

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER

DIPHENHYDRAMINE HCI / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves aches, fever, sore throat, nasal congestion, runny nose & sneezing
  • Controls cough  
  • For ages 12 & over

DAYTIME

DAYTIME

Severe Cold

ACETAMINOPHEN / PAIN RELIEVER & FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves aches, fever & sore throat
  • Controls Cough
  • Clear nasal & chest congestion 
  • Thins & loosens mucus 
  • For ages 12 & over

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

↑↑This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Severe Cold & Nighttime Cold & Flu.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using These Products (When using these products)

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicile or operating machinery

Daytime

  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or last 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 a signs of a serious condition

 Daytime

  • nervousness, dizziness or sleeplessness occur
  • pain, 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,)

Nighttime and DayTime

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Nighttime and DayTime

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.

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

Nighttime

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

Daytime

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients for Daytime (in Each 20 Ml) (Active ingredients for Daytime (in each 20 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifeenesin 400 mg

Phenylephrine HCl 10 mg

Active Ingredients for Nighttime (in Each 20 Ml) (Active ingredients for Nighttime (in each 20 mL))

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg 

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

Nighttime

  • you are taking the blood thinning drug warfarin
  • you are taking sedative or tranquilizers

Daytime

  • taking the blood thinning drug warfarin

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Source: dailymed · Ingested: 2026-02-15T12:01:20.913433 · Updated: 2026-03-14T23:01:22.645369