Kirkland 44-519-acetaminophen

Kirkland 44-519-acetaminophen
SPL v7
SPL
SPL Set ID 3745aa18-a711-43ed-9bc4-1f087b3c53c0
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Shellac Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L;5 Shape: oval Color: red Color: blue Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-12

Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • backache
    • the common cold
    • muscular aches
    • headache
    • toothache
    • minor pain of arthritis
    • premenstrual and menstrual cramps
  • 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 take more than directed
  • adults and children 12 years and over
    • take 2 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps 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

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.

Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
  • avoid high humidity
Inactive Ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Principal Display Panel

KIRKLAND

Signature

COMPARE TO

EXTRA STRENGTH TYLENOL®

RAPID RELEASE


active ingredient*

NDC 63981-019-05

ITM. / ART. 355476

EXTRA STRENGTH

ACETAMINOPHEN

GELCAPS, 500 mg

Pain Reliever/Fever Reducer

  Temporarily Relieves:

• Headache

• Minor Pain of Arthritis

• Muscular Aches

• Backaches

Actual

Size

400

Gelcaps

500 mg EACH

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Extra Strength Tylenol® Rapid Release.

50844       REV0525T51905

Manufactured by: LNK INTERNATIONAL, INC., 60 Arkay Drive, Hauppauge, NY 11788 USA 1-800-426-9391

Distributed by: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027 USA

www.costco.com           22V13038a

Kirkland signature 44-519
Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days 
  • redness or swelling is present
  • 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.

Active Ingredient (in Each Gelcap)

Acetaminophen 500 mg

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.


Structured Label Content

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

Pain reliever/fever reducer

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 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps 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

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.

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
  • avoid high humidity
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Principal Display Panel

KIRKLAND

Signature

COMPARE TO

EXTRA STRENGTH TYLENOL®

RAPID RELEASE


active ingredient*

NDC 63981-019-05

ITM. / ART. 355476

EXTRA STRENGTH

ACETAMINOPHEN

GELCAPS, 500 mg

Pain Reliever/Fever Reducer

  Temporarily Relieves:

• Headache

• Minor Pain of Arthritis

• Muscular Aches

• Backaches

Actual

Size

400

Gelcaps

500 mg EACH

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Extra Strength Tylenol® Rapid Release.

50844       REV0525T51905

Manufactured by: LNK INTERNATIONAL, INC., 60 Arkay Drive, Hauppauge, NY 11788 USA 1-800-426-9391

Distributed by: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027 USA

www.costco.com           22V13038a

Kirkland signature 44-519
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 10 days 
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Gelcap) (Active ingredient (in each gelcap))

Acetaminophen 500 mg

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

liver disease.

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


Raw Label Data

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