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NDC 63981-0556-54 Rapid Release Acetaminophen PM 500; 25 mg/1; mg/1 Details

Rapid Release Acetaminophen PM 500; 25 mg/1; mg/1

Rapid Release Acetaminophen PM is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by COSTCO WHOLESALE CORPORATION. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 63981-0556-54
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 63981-0556-54
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	63981-0556
Product ID	63981-556_4368fb2a-a593-48a0-9a5f-3b8ea053225b
Associated GPIs	60309902200310
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Rapid Release Acetaminophen PM
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	Acetaminophen and Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	500; 25
Active Ingredient Units	mg/1; mg/1
Substance Name	ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	COSTCO WHOLESALE CORPORATION
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 63981-0556-54 (63981055654)

Pricing Information	N/A
NDC Package Code	63981-556-54
Billing NDC	63981055654
Package	375 TABLET, COATED in 1 BOTTLE, PLASTIC (63981-556-54)
Marketing Start Date	2007-12-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e67bd3b7-03bc-4164-b9c2-4dd679ce6916 Details

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

INGREDIENTS AND APPEARANCE

RAPID RELEASE ACETAMINOPHEN PM EXTRA STRENGTH

acetaminophen and diphenhydramine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63981-556
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
AMMONIA (UNII: 5138Q19F1X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN (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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue (Dark) , blue (Light)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	L;6
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63981-556-54	375 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2007	10/27/2024
2	NDC:63981-556-24	1 in 1 CARTON	12/17/2007	10/01/2021
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	12/17/2007	10/27/2024

Labeler - COSTCO WHOLESALE CORPORATION (103391843)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(63981-556)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(63981-556)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(63981-556) , pack(63981-556)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(63981-556)

Revised: 11/2022

Document Id: 4368fb2a-a593-48a0-9a5f-3b8ea053225b

Set id: e67bd3b7-03bc-4164-b9c2-4dd679ce6916

Version: 17

Effective Time: 20221119