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
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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.