RAPID RELEASE ACETAMINOPHEN Extra Strength

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

Medically reviewed by Drugs.com. Last updated on Sep 5, 2022.

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63981-519
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
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
Color	RED, BLUE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L;5
Contains

Packaging
#	Item Code	Package Description
1	NDC:63981-519-24	1 BLISTER PACK in 1 CARTON
1		2 TABLET in 1 BLISTER PACK
2	NDC:63981-519-05	400 TABLET in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/10/2004

Labeler - COSTCO WHOLESALE CORPORATION (103391843)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	PACK(63981-519)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	MANUFACTURE(63981-519), PACK(63981-519)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	PACK(63981-519)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		868734088	PACK(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