Winco 44-502 - DailyMed Details

Winco 44-502

SPL v14

SPL

SPL Set ID fab51b36-1c2e-4c97-932c-dacfaf55935a

Route

ORAL

Published

Effective Date 2025-05-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Phenylephrine (5 mg)

Inactive Ingredients

Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;502 Shape: oval Color: orange Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2005-06-23

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer

Nasal decongestant

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- minor aches and pains
- nasal congestion
- headache
- sinus congestion and pressure
promotes sinus drainage
temporarily reduces fever

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 use 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.
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

Questions?

Call 1-800-824-1706 Monday - Friday 9am - 4pm MST

Other Information

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

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Principal Display Panel

WinCo^®

FOODS

MAXIMUM STRENGTH

Nasal

Decongestant PE

& Pain Relief

ACETAMINOPHEN/

PAIN RELIEVER - FEVER REDUCER

PHENYLEPHRINE HCl/NASAL DECONGESTANT

*Compare to the active ingredients in

SUDAFED PE^® Pressure + Pain

Non-Drowsy

Relives: Sinus Headache,

Sinus Pressure

& Nasal Congestion

24

Caplets

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by JOHNSON & JOHNSON CORPORATION,

distributor of SUDAFED PE^® Pressure + Pain.

50844 REV0820C50208 WF2208

100% SATISFACTION GUARANTEE

Comments & Questions? 800-824-1706

Winco 44-502

When Using This Product

do not exceed recommended dosage.

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

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 accidental 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 Caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

diabetes
liver disease
heart disease
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- minor aches and pains
- nasal congestion
- headache
- sinus congestion and pressure
promotes sinus drainage
temporarily reduces fever

Purpose

Pain reliever/fever reducer

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 use 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.
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

Questions?

Call 1-800-824-1706 Monday - Friday 9am - 4pm MST

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Principal Display Panel

WinCo^®

FOODS

MAXIMUM STRENGTH

Nasal

Decongestant PE

& Pain Relief

ACETAMINOPHEN/

PAIN RELIEVER - FEVER REDUCER

PHENYLEPHRINE HCl/NASAL DECONGESTANT

*Compare to the active ingredients in

SUDAFED PE^® Pressure + Pain

Non-Drowsy

Relives: Sinus Headache,

Sinus Pressure

& Nasal Congestion

24

Caplets

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by JOHNSON & JOHNSON CORPORATION,

distributor of SUDAFED PE^® Pressure + Pain.

50844 REV0820C50208 WF2208

100% SATISFACTION GUARANTEE

Comments & Questions? 800-824-1706

Winco 44-502

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
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

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 Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

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

diabetes
liver disease
heart disease
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage temporarily reduces fever", "Purpose": "Pain reliever/fever reducer 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 use 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. 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 ", "Questions?": "Call 1-800-824-1706 Monday - Friday 9am - 4pm MST ", "Other information": "TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid ", "Principal Display Panel": "WinCo ® FOODS MAXIMUM STRENGTH Nasal Decongestant PE & Pain Relief ACETAMINOPHEN/ PAIN RELIEVER - FEVER REDUCER PHENYLEPHRINE HCl/NASAL DECONGESTANT *Compare to the active ingredients in SUDAFED PE ® Pressure + Pain Non-Drowsy Relives: Sinus Headache, Sinus Pressure & Nasal Congestion 24 Caplets TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704 *This product is not manufactured or distributed by JOHNSON & JOHNSON CORPORATION, distributor of SUDAFED PE ® Pressure + Pain. 50844 REV0820C50208 WF2208 100% SATISFACTION GUARANTEE Comments & Questions? 800-824-1706 Winco 44-502", "When using this product": "do not exceed recommended dosage. ", "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 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 accidental 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 caplet)": "Acetaminophen 325 mg Phenylephrine HCl 5 mg", "Ask a doctor before use if you have": "diabetes liver disease heart disease thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin. "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:06.507905 · Updated: 2026-03-14T23:08:42.212838