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RAPID RELEASE ACETAMINOPHEN Extra Strength

Medically reviewed by Drugs.com. Last updated on Sep 13, 2019.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: COSTCO WHOLESALE CORPORATION
NDC Code: 63981-519

Kirkland 44-519

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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • 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
  • 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 25ºC (77ºF); 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

Primary Display Panel

KIRKLAND
Signature™

COMPARE TO EXTRA STRENGTH TYLENOL® RAPID RELEASE active ingredient*

NDC 63981-519-05
ITM. / ART. 355476

EXTRA STRENGTH
RAPID RELEASE
ACETAMINOPHEN
Pain Reliever/Fever Reducer

Temporarily Relieves:
✓ Headache
✓Minor Pain of Arthritis
✓Muscular Aches
✓Backaches

Actual
Size

400
 Rapid Release
Gelcaps
500 mg EACH

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® Rapid Release.
This product does not contain gluten.

Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA 1-800-426-9391
For: Costco Wholesale Corporation, P.O. Box 34535
Seattle, WA 98124-1535 USA 1-800-774-2678
www.costco.com  17V0219a

50844     REV0417P51905

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

44-519


RAPID RELEASE ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-519
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYPROMELLOSES 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
FERROSOFERRIC OXIDE 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
STARCH, CORN 
SHELLAC 
Product Characteristics
ColorRED, BLUEScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;5
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-519-241 BLISTER PACK in 1 CARTON
12 TABLET in 1 BLISTER PACK
2NDC:63981-519-05400 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - COSTCO WHOLESALE CORPORATION (103391843)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63981-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(63981-519), PACK(63981-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63981-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63981-519)

Document Id: 3e666c8c-ad06-47e3-b4a8-26565e206efd
Set id: 4fac481f-9782-1127-226b-b8e05a7fff78
Version: 16
Effective Time: 20190913
 
COSTCO WHOLESALE CORPORATION

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer