Walgreens 44-004063-45

Walgreens 44-004063-45
SPL v4
SPL
SPL Set ID b75af815-9bd4-4a7a-bc68-f42f4af50699
Route
ORAL
Published
Effective Date 2025-12-16
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) Triprolidine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin 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 2023-10-23
Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Cough suppressant Expectorant Nasal decongestant

Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold
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:

  • rash
  • blisters
  • skin reddening

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
  • 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
Do Not Use

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.



Other Information
  • each 20 mL contains: sodium 9 mg
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 0363-4063-45

DAY & NIGHT PACK

  Walgreens

• WALGREENS •

PHARMACIST RECOMMENDED †

Compare to the active ingredients in

MAXIMUM STRENGTH MUCINEX FAST-MAX® Severe

Congestion & Cough & NIGHTSHIFT® Cold & Flu††

Severe

Congestion

& Cough

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

• Controls cough

• Relieves nasal & chest congestion

• Thins & loosens mucus

• 12 years & older

NIGHTTIME

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

TRIPROLIDINE HCl / ANTIHISTAMINE

Multi-Symptom

• Relieves cough, fever, sore throat,

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do not take Severe Congestion

& Cough and Nighttime

Cold & Flu at the same time.

50844     REV0724A00406345

†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®

and NIGHTSHIFT®.

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2025 Walgreen Co.

Walgreens 44-004063
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • difficulty in urination due to enlargement of the prostate gland
  • thyroid disease
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • high blood pressure
  • heart disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold
Purpose

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:

  • rash
  • blisters
  • skin reddening

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
  • 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
Do Not Use (Do not use)

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.



Other Information (Other information)
  • each 20 mL contains: sodium 9 mg
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

NDC 0363-4063-45

DAY & NIGHT PACK

  Walgreens

• WALGREENS •

PHARMACIST RECOMMENDED †

Compare to the active ingredients in

MAXIMUM STRENGTH MUCINEX FAST-MAX® Severe

Congestion & Cough & NIGHTSHIFT® Cold & Flu††

Severe

Congestion

& Cough

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

• Controls cough

• Relieves nasal & chest congestion

• Thins & loosens mucus

• 12 years & older

NIGHTTIME

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

TRIPROLIDINE HCl / ANTIHISTAMINE

Multi-Symptom

• Relieves cough, fever, sore throat,

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do not take Severe Congestion

& Cough and Nighttime

Cold & Flu at the same time.

50844     REV0724A00406345

†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®

and NIGHTSHIFT®.

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2025 Walgreen Co.

Walgreens 44-004063
When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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.

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

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • difficulty in urination due to enlargement of the prostate gland
  • thyroid disease
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • high blood pressure
  • heart disease
  • diabetes
  • 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:49.720030 · Updated: 2026-03-14T23:11:28.912883