Walgreens 44-078

SPL v3

SPL

SPL Set ID 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3

Route

ORAL

Published

Effective Date 2025-10-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg) Triprolidine (2.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-21

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg Triprolidine HCl 2.5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant Antihistamine

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Antihistamine

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg Triprolidine HCl 2.5 mg

Uses

temporarily relieves these common cold and flu symptoms:

nasal congestion
sore throat
minor aches and pains
cough
sinus congestion and pressure
sneezing
itching of the nose or throat
runny nose
itchy, watery eyes due to hay fever
headache

temporarily reduces fever
controls cough to help you get to sleep

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.

Directions

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

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

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

Inactive Ingredients

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 0363-8078-45

Walgreens

• WALGREENS •

PHARMACIST RECOMMENDED†

Compare to the active ingredients in

Maximum Strength Mucinex®

NIGHTSHIFT® Severe Cold & Flu††

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

6 FL OZ (177 mL)

†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 trademark Maximum Strength

Mucinex® NIGHTSHIFT® Severe Cold & Flu.

DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2023 Walgreen Co.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens 44-078

When Using This Product

do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution 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
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.

Active Ingredients (in Each 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Triprolidine HCl 2.5 mg

Ask A Doctor Before Use If You Have

diabetes
cough that occurs with too much phlegm (mucus)
heart disease
liver disease
difficulty in urination due to enlargement of the prostate gland
high blood pressure
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
glaucoma
a breathing problem such as emphysema or chronic bronchitis
thyroid disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms:

nasal congestion
sore throat
minor aches and pains
cough
sinus congestion and pressure
sneezing
itching of the nose or throat
runny nose
itchy, watery eyes due to hay fever
headache

temporarily reduces fever
controls cough to help you get to sleep

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Antihistamine

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.

Directions

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

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)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 0363-8078-45

Walgreens

• WALGREENS •

PHARMACIST RECOMMENDED†

Compare to the active ingredients in

Maximum Strength Mucinex®

NIGHTSHIFT® Severe Cold & Flu††

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

6 FL OZ (177 mL)

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens 44-078

When Using This Product (When using this product)

do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution 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
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.)

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

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Triprolidine HCl 2.5 mg

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

diabetes
cough that occurs with too much phlegm (mucus)
heart disease
liver disease
difficulty in urination due to enlargement of the prostate gland
high blood pressure
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
glaucoma
a breathing problem such as emphysema or chronic bronchitis
thyroid disease

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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold and flu symptoms: nasal congestion sore throat minor aches and pains cough sinus congestion and pressure sneezing itching of the nose or throat runny nose itchy, watery eyes due to hay fever headache temporarily reduces fever controls cough to help you get to sleep", "Purpose": "Pain reliever/fever reducer Cough suppressant Nasal decongestant Antihistamine", "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.", "Directions": "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", "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": "store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package", "Inactive ingredients": "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", "Questions or comments?": "1-800-426-9391", "Principal display panel": "NDC 0363-8078-45 Walgreens • WALGREENS • PHARMACIST RECOMMENDED† Compare to the active ingredients in Maximum Strength Mucinex® NIGHTSHIFT® Severe Cold & Flu†† 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 6 FL OZ (177 mL) †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 trademark Maximum Strength Mucinex® NIGHTSHIFT® Severe Cold & Flu. DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2023 Walgreen Co. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Walgreens 44-078", "When using this product": "do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution 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 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.", "Active ingredients (in each 20 mL)": "Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg Triprolidine HCl 2.5 mg", "Ask a doctor before use if you have": "diabetes cough that occurs with too much phlegm (mucus) heart disease liver disease difficulty in urination due to enlargement of the prostate gland high blood pressure persistent or chronic cough such as occurs with smoking, asthma, or emphysema glaucoma a breathing problem such as emphysema or chronic bronchitis thyroid disease", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:44.389812 · Updated: 2026-03-14T23:13:07.898715