Walgreens 44-543 Ar

SPL v6

SPL

SPL Set ID 0a6e3251-02e0-42c1-bdf3-51c77f88c17f

Route

ORAL

Published

Effective Date 2025-12-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Diphenhydramine (25 mg) Phenylephrine (5 mg)

Inactive Ingredients

Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: 44;543 Shape: oval Color: blue Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-11-04

Description

Acetaminophen 325 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Antihistamine Nasal decongestant

Medication Information

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- headache
- nasal congestion
- sneezing
- runny nose
- sinus congestion and pressure
- itchy, watery eyes
- itching of the nose or throat
- minor aches and pains

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.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor

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 product containing diphenhydramine, even one used on 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.

Other Information

see end flap for expiration date and lot number
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Walgreens

WALGREENS PHARMACIST RECOMMENDED^†

Allergy Relief

ALLERGY & SINUS HEADACHE

ACETAMINOPHEN / PAIN RELIEVER

DIPHENHYDRAMINE HCl / ANTIHISTAMINE

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

• Relief of headache. sinus congestion, sinus pain & pressure,

runny nose, sneezing, itchy throat & itchy, watery eyes

20 CAPLETS

ACTUAL SIZE

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

©2025 Walgreen Co.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

NDC 0363-5430-09

50844 REV0825A54309

^†Our pharmacists

recommend the

Walgreens brand.

Walgreens 44-543

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
use caution when driving a motor vehicle or operating machinery
avoid alcoholic beverages

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion 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

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.

Ask A Doctor Before Use If You Have

glaucoma
heart disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis
liver disease
thyroid disease
diabetes

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

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 symptoms of hay fever or other upper respiratory allergies:
- headache
- nasal congestion
- sneezing
- runny nose
- sinus congestion and pressure
- itchy, watery eyes
- itching of the nose or throat
- minor aches and pains

Purpose

Pain reliever

Antihistamine

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.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor

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 product containing diphenhydramine, even one used on 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.

Other Information (Other information)

see end flap for expiration date and lot number
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

Walgreens

WALGREENS PHARMACIST RECOMMENDED^†

Allergy Relief

ALLERGY & SINUS HEADACHE

ACETAMINOPHEN / PAIN RELIEVER

DIPHENHYDRAMINE HCl / ANTIHISTAMINE

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

• Relief of headache. sinus congestion, sinus pain & pressure,

runny nose, sneezing, itchy throat & itchy, watery eyes

20 CAPLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

NDC 0363-5430-09

50844 REV0825A54309

^†Our pharmacists

recommend the

Walgreens brand.

Walgreens 44-543

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
use caution when driving a motor vehicle or operating machinery
avoid alcoholic beverages

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion 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

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.)

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

glaucoma
heart disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis
liver disease
thyroid disease
diabetes

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache nasal congestion sneezing runny nose sinus congestion and pressure itchy, watery eyes itching of the nose or throat minor aches and pains", "Purpose": "Pain reliever Antihistamine 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.", "Directions": "do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor", "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 product containing diphenhydramine, even one used on 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.", "Other information": "see end flap for expiration date and lot number TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)", "Inactive ingredients": "corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin", "Questions or comments?": "1-800-426-9391", "Principal display panel": "Walgreens WALGREENS PHARMACIST RECOMMENDED † Allergy Relief ALLERGY & SINUS HEADACHE ACETAMINOPHEN / PAIN RELIEVER DIPHENHYDRAMINE HCl / ANTIHISTAMINE PHENYLEPHRINE HCl / NASAL DECONGESTANT Maximum Strength • Relief of headache. sinus congestion, sinus pain & pressure, runny nose, sneezing, itchy throat & itchy, watery eyes 20 CAPLETS ACTUAL SIZE DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2025 Walgreen Co. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING NDC 0363-5430-09 50844 REV0825A54309 † Our pharmacists recommend the Walgreens brand. Walgreens 44-543", "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 use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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", "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.", "Ask a doctor before use if you have": "glaucoma heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis liver disease thyroid disease diabetes", "Active ingredients (in each caplet)": "Acetaminophen 325 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 5 mg", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:35.469318 · Updated: 2026-03-14T23:11:13.760766