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Pain Reliever

Pain Reliever

Approved
Approval ID

f7667529-09c0-4603-8080-f236144fac36

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 24, 2025

Manufacturers
FDA

Walgreen Company

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-0175
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2025
FDA Product Classification

INGREDIENTS (7)

ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/24/2025

Principal Display Panel

Walgreens


Compare to the active ingredient in
Tylenol® Extra Strength Caplets††

Pain Reliever
ACETAMINOPHEN 500 mg
PAIN RELIEVER/FEVER REDUCER

Extra Strength

10CAPLETS

ACTUAL SIZE

OPEN HERE TO VIEW COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF PRINTED
** TEAR STRIP IS BROKEN OR MISSING**

Walgreens Pharmacist Recommended.
Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.

††This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark Tylenol®
Extra Strength Caplets.

DISTRIBUTED BY:WALGREEN CO.
DEERFIELD, IL 60015
** 100% SATISFACTION GUARANTEED**
walgreens.com ©2025 Walgreen Co.

50844
REV1024B17503

Walgreens 44-175

Walgreens 44-175

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/24/2025

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • the common cold
    • backache
    • toothache
    • minor pain from arthritis
    • premenstrual and menstrual cramps
  • temporarily reduces fever

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/24/2025

Active ingredient (in each caplet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/24/2025

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 9/24/2025

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
  • skin reddening
  • blisters

If a skin reaction occurs, stop use and seek medical help right away.

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.

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/24/2025

Directions

*do not take more than directed

  • adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/24/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/24/2025

Inactive ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/24/2025

Questions or comments?

1-800-426-9391

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