Walgreens 44-042078

Walgreens 44-042078
SPL v3
SPL
SPL Set ID afbe932c-c26a-4fac-9ea3-d050db01eded
Route
ORAL
Published
Effective Date 2025-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Triprolidine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sodium Metabisulfite Sorbitol Sucralose Xanthan Gum Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-21

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 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 Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg 

Uses
  • temporarily relieves these common cold and flu symptoms:

    • sore throat

    • nasal congestion

    • stuffy nose

    • minor aches and pains

    • sneezing (Nighttime only)

    • headache

    • cough

    • runny nose (Nighttime only)

    • itching of the nose or throat (Nighttime only)

    • itchy, watery eyes due to hay fever (Nighttime only)

    • sinus congestion and pressure

  • temporarily reduces fever

  • controls cough to help you get to sleep

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

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.

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information
  • each 20 mL contains: sodium 10 mg (Daytime only)

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Questions Or Comments?

1-800-426-9391

Principal Display Panel

DAY & NIGHT PACK

NDC 0363-4278-45

Walgreens

• WALGREENS •

PHARMACIST RECOMMENDED†

Compare to the active ingredients in Maximum

Strength Mucinex® FAST-MAX® Cold & Flu

& NIGHTSHIFT® Severe Cold & Flu††





DAYTIME

Cold & Flu




ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

 

Maximum Strength

• Relieves headache, body pain,

  sore throat, fever, chest congestion,

  cough, nasal congestion,

  sinus congestion & pressure

• 12 years & older

 

 

 

 

 

NIGHTTIME

Severe

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

TRIPROLIDINE HCl / ANTIHISTAMINE

Maximum Strength

• Relieves headache, body pain,

   sore throat, fever, itchy throat, cough,

   nasal congestion, runny nose & sneezing

• 12 years & older



2 – 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

Do not take Daytime Cold & Flu and Nighttime

Severe Cold & Flu at the same time.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2023 Walgreen Co.

†Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

††This product is not manufactured or distributed by RB Health (US) LLC, owner

of the registered trademarks Maximum Strength Mucinex® FAST-MAX® Cold &

Flu and NIGHTSHIFT® Severe Cold & Flu.

50844  ORG102304207845

Walgreens 44-042078


When Using This Product
  • do not exceed recommended dosage

  • excitability may occur, especially in children (Nighttime only)

  • marked drowsiness may occur (Nighttime only)

  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

  • avoid alcoholic beverages (Nighttime only)

  • use caution when driving a motor vehicle or operating machinery (Nighttime only)

Directions (daytime Only)
  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use
Directions (nighttime Only)
  • do not take more than directed
  • do not take more than 4 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use
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
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.

Ask A Doctor Before Use If You Have
  • liver disease
  • diabetes
  • thyroid disease

  • heart disease
  • glaucoma (Nighttime only)

  • difficulty in urination due to enlargement of the prostate gland

  • cough that occurs with too much phlegm (mucus)

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • high blood pressure

Inactive Ingredients (daytime Only)

anhydrous citric acid, disodium edetate, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Inactive Ingredients (nighttime Only)

anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

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

  • taking sedatives or tranquilizers (Nighttime only)

Active Ingredients (in Each 20 Ml) (daytime Cold & Flu)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg 

Active Ingredients (in Each 20 Ml) (nighttime Severe Cold & Flu)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Triprolidine HCl 2.5 mg


Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:

    • sore throat

    • nasal congestion

    • stuffy nose

    • minor aches and pains

    • sneezing (Nighttime only)

    • headache

    • cough

    • runny nose (Nighttime only)

    • itching of the nose or throat (Nighttime only)

    • itchy, watery eyes due to hay fever (Nighttime only)

    • sinus congestion and pressure

  • temporarily reduces fever

  • controls cough to help you get to sleep

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

  • 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.

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • each 20 mL contains: sodium 10 mg (Daytime only)

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

DAY & NIGHT PACK

NDC 0363-4278-45

Walgreens

• WALGREENS •

PHARMACIST RECOMMENDED†

Compare to the active ingredients in Maximum

Strength Mucinex® FAST-MAX® Cold & Flu

& NIGHTSHIFT® Severe Cold & Flu††





DAYTIME

Cold & Flu




ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

 

Maximum Strength

• Relieves headache, body pain,

  sore throat, fever, chest congestion,

  cough, nasal congestion,

  sinus congestion & pressure

• 12 years & older

 

 

 

 

 

NIGHTTIME

Severe

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

TRIPROLIDINE HCl / ANTIHISTAMINE

Maximum Strength

• Relieves headache, body pain,

   sore throat, fever, itchy throat, cough,

   nasal congestion, runny nose & sneezing

• 12 years & older



2 – 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

Do not take Daytime Cold & Flu and Nighttime

Severe Cold & Flu at the same time.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2023 Walgreen Co.

†Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

††This product is not manufactured or distributed by RB Health (US) LLC, owner

of the registered trademarks Maximum Strength Mucinex® FAST-MAX® Cold &

Flu and NIGHTSHIFT® Severe Cold & Flu.

50844  ORG102304207845

Walgreens 44-042078


When Using This Product (When using this product)
  • do not exceed recommended dosage

  • excitability may occur, especially in children (Nighttime only)

  • marked drowsiness may occur (Nighttime only)

  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

  • avoid alcoholic beverages (Nighttime only)

  • use caution when driving a motor vehicle or operating machinery (Nighttime only)

Directions (daytime Only) (Directions (Daytime only))
  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use
Directions (nighttime Only) (Directions (Nighttime only))
  • do not take more than directed
  • do not take more than 4 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use
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
  • 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.)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • diabetes
  • thyroid disease

  • heart disease
  • glaucoma (Nighttime only)

  • difficulty in urination due to enlargement of the prostate gland

  • cough that occurs with too much phlegm (mucus)

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • high blood pressure

Inactive Ingredients (daytime Only) (Inactive ingredients (Daytime only))

anhydrous citric acid, disodium edetate, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Inactive Ingredients (nighttime Only) (Inactive ingredients (Nighttime only))

anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

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 (Nighttime only)

Active Ingredients (in Each 20 Ml) (daytime Cold & Flu) (Active ingredients (in each 20 mL) (Daytime Cold & Flu))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg 

Active Ingredients (in Each 20 Ml) (nighttime Severe Cold & Flu) (Active ingredients (in each 20 mL) (Nighttime Severe Cold & Flu))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Triprolidine HCl 2.5 mg


Advanced Ingredient Data


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