ACETAMINOPHEN tablet, coated

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by COSTCO WHOLESALE CORPORATION, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63981-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red, blue	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63981-019-05	400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2022

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	Business Operations
LNK International, Inc.		038154464	manufacture(63981-019) , pack(63981-019)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(63981-019)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(63981-019)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(63981-019)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(63981-019)