Acetaminophen PM
Kirkland 44-556-Acetaminophen PM
e03dfa65-1a9c-4284-89cf-19ccbaabfa32
HUMAN OTC DRUG LABEL
Sep 12, 2025
COSTCO WHOLESALE CORPORATION
DUNS: 103391843
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (21)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal display panel
KIRKLAND
****Signature
COMPARE TO EXTRA
** STRENGTH TYLENOL® PM**
***active ingredients
NDC 63981-056-54
ITM. / ART. 596759
EXTRA STRENGTH
** ACETAMINOPHEN**PM****
****GELCAPS
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever • Nighttime Sleep Aid
Non-Habit Forming
Temporarily Relieves:
• Headache
• Minor Aches and
Pains Accompanied
by Sleeplessness
Actual
Size
375
Gelcaps
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
** SAFETY SEAL UNDER CAP IS BROKEN OR MISSING**
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark
Extra Strength Tylenol® PM. 50844 REV0324N55654
Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
Distributed by: Costco Wholesale Corporation
999 Lake Drive, Issaquah, WA 98027 USA
www.costco.com 22V13037a

Kirkland 44-556
INDICATIONS & USAGE SECTION
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each gelcap)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever
Nighttime sleep-aid
WARNINGS SECTION
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.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- any new symptoms appear
- redness or swelling is present
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
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.
DOSAGE & ADMINISTRATION SECTION
Directions
*do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours
- children under 12 years: do not use
STORAGE AND HANDLING SECTION
Other information
- use by expiration date on package
- avoid high humidity
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-426-9391