Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a33ae35b-1cde-4a3d-a836-3b169e4f1bb9
Route
ORAL
Published
Effective Date 2023-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-27

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer  Antihistamine/Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer  Antihistamine/Cough suppressant Nasal decongestant

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny  nose
    • sneezing
    • sinus congestion and pressure
    • itching of the nose or throat
  • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep 
Purposes

Pain reliever/fever reducer 

Antihistamine/Cough suppressant

Nasal decongestant

Warnings

Liver warnings: 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 daily 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
  • do not take more than directed (see overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measue only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • dose as follows or as directed by a doctor 
  • adults and children 12 years of age and older: 20 mL  every 4 hours while symptoms last 
  • children under 12 years of age: 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.
  • 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.
Package Label
WALGREENS Mucus Relief Nighttime Cold & Flu
Other Information
  • each 20 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

anhydrous 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

Principal Display Panel

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

NIGHTTIME

Cold &Flu

ACETAMINOPHEN 650 mg /

PAIN RELIEVER / FEVER REDUCER

DIPHENHYDRAMINE HCl 25 mg /

ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCl 10 mg /

NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves cough, fever, sore throat,body pain, sneezing, itchy throat, headache, nasal congestion & runny nose
  • 12 years & older

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max®  All-in-One Night Time Cold & Flu.

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

DISTRIBUTED BY WALGREENS CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using This Product,
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, 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 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

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem  or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)



Ask A Doctor Or Pharmacist Before Use If You Are
  •  taking the blood thinning drug warfarin.
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny  nose
    • sneezing
    • sinus congestion and pressure
    • itching of the nose or throat
  • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep 
Purposes

Pain reliever/fever reducer 

Antihistamine/Cough suppressant

Nasal decongestant

Warnings

Liver warnings: 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 daily 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
  • do not take more than directed (see overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measue only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • dose as follows or as directed by a doctor 
  • adults and children 12 years of age and older: 20 mL  every 4 hours while symptoms last 
  • children under 12 years of age: 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.
  • 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.
Package Label
WALGREENS Mucus Relief Nighttime Cold & Flu
Other Information (Other information)
  • each 20 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous 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

Principal Display Panel

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

NIGHTTIME

Cold &Flu

ACETAMINOPHEN 650 mg /

PAIN RELIEVER / FEVER REDUCER

DIPHENHYDRAMINE HCl 25 mg /

ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCl 10 mg /

NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves cough, fever, sore throat,body pain, sneezing, itchy throat, headache, nasal congestion & runny nose
  • 12 years & older

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max®  All-in-One Night Time Cold & Flu.

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

DISTRIBUTED BY WALGREENS CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using This Product, (When using this product,)
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, 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 adults as well as for children even if you do not notice any signs or symptoms.

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

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem  or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)



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.
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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