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Rapid Release Acetaminophen PM Extra Strength

Medically reviewed by Drugs.com. Last updated on Apr 15, 2020.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: COSTCO WHOLESALE CORPORATION
NDC Code: 63981-556

Kirkland 44-556

Active ingredients (in each gelcap)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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
  • 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
  • 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
  • new symptoms occur
  • 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. 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 at bedtime
    • do not take more than 2 gelcaps of this product in 24 hours
  • children under 12 years: do not use 

Other information
  • use by expiration date on package
  • avoid high humidity
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

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

Questions or comments?
1-800-426-9391

Principal Display Panel

KIRKLAND
Signature

COMPARE TO EXTRA STRENGTH TYLENOL® PM
active ingredients*

NDC 63981-556-54
ITM./ART. 596759

EXTRA STRENGTH
RAPID RELEASE
ACETAMINOPHEN PM

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
Rapid Release Gelcaps

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

Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For: Costco Wholesale Corporation
P.O. Box 34535, Seattle, WA 98124-1535 USA    
1-800-774-2678 www.costco.com        17V0218a

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® PM.

50844    REV0417J55654

This product does not contain gluten.

 

Kirkland 44-556


RAPID RELEASE ACETAMINOPHEN PM  EXTRA STRENGTH
acetaminophen and diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-556
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 3 
HYPROMELLOSE, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
GELATIN 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
MICROCRYSTALLINE CELLULOSE 
POVIDONE 
STARCH, CORN 
SHELLAC 
DIMETHICONE 
AMMONIA 
Product Characteristics
ColorBLUE (Dark) , BLUE (Light) Scoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;6
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-556-241 BLISTER PACK in 1 CARTON
12 TABLET in 1 BLISTER PACK
2NDC:63981-556-54375 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/17/2007
Labeler - COSTCO WHOLESALE CORPORATION (103391843)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63981-556)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(63981-556), PACK(63981-556)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63981-556)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63981-556)

 
COSTCO WHOLESALE CORPORATION

Further information

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