OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen tablet, coated
COSTCO WHOLESALE CORPORATION

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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.

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 allergic to acetaminophen or any of the inactive ingredients in this product

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

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

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.

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

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 Johnson & Johnson Corporation,
owner of the registered trademark Extra Strength Tylenol® Rapid Release.
50844 REV0322R51905

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 44-519
(click image for full-size original)

Kirkland 44-519

ACETAMINOPHEN acetaminophen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-019
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color red, blue Score no score
Shape OVAL Size 19mm
Flavor Imprint Code L;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63981-019-05 400 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 10/12/2022
Labeler — COSTCO WHOLESALE CORPORATION (103391843)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 manufacture (63981-019), pack (63981-019)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (63981-019)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (63981-019)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (63981-019)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (63981-019)

Revised: 08/2023 COSTCO WHOLESALE CORPORATION

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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