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NDC 63739-0087-02 Acetaminophen 325mg 325 mg/1 Details

Acetaminophen 325mg 325 mg/1

Acetaminophen 325mg is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by McKesson Corporation dba SKY Packaging. The primary component is ACETAMINOPHEN.

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: 63739-0087-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	63739-0087
Product ID	63739-087_c6f3afc6-0b4a-13cc-e053-2a95a90a6222
Associated GPIs	64200010000310
GCN Sequence Number	004489
GCN Sequence Number Description	acetaminophen TABLET 325 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16964
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Acetaminophen 325mg
Proprietary Name Suffix	RS
Non-Proprietary Name	Acetaminophen 325mg
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	325
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	McKesson Corporation dba SKY Packaging
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2022-12-31

Package

Package Images

NDC 63739-0087-02 (63739008702)

Pricing Information
NDC Package Code	63739-087-02
Billing NDC	63739008702
Package	30 BLISTER PACK in 1 BOX (63739-087-02) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	2021-07-12
NDC Exclude Flag	N
Price Per Unit	0.0226
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ACETAMINOPHEN 325 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL c6f41729-840e-0db5-e053-2a95a90aea7e Details

Active Ingredient (in each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer

Uses

temporary relief of minor aches and pains associated with:

headache
backache
muscular aches
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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 acetamiophen
with other products 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 user has

liver disease.

Ask a doctor or pharmacist before use if

the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

symptoms do not improve
pain gets worse or lasts for more than 10 days
pain gets worse or lasts more than 5 days in children under 12 years
fever gets worse or lasts for more than 3 days
new symptoms occur
redness or swelling is present
a rare sensitivity reaction occurs
You may report side effects to 1-888-952-0050

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and over: Take 2 tablets every 4 to 6 hours.

Do not take more than 10 tablets in 24 hours.

Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.

Do not take more than 5 tablets in 24 hours.

Children under 6 years of age: Do not use this regular strenght product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

store at room temperature
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 325MG RS

acetaminophen 325mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63739-087(NDC:69168-010)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (Round Circle)	Size	11mm
Flavor		Imprint Code	AZ;010
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63739-087-02	30 in 1 BOX	07/12/2021
1		10 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	07/12/2021

Labeler - McKesson Corporation dba SKY Packaging (140529962)

Name	Address	ID/FEI	Business Operations
Establishment
Legacy Pharmaceutical Packaging, LLC		143213275	relabel(63739-087) , repack(63739-087)

Revised: 7/2021

Document Id: c6f3afc6-0b4a-13cc-e053-2a95a90a6222

Set id: c6f41729-840e-0db5-e053-2a95a90aea7e

Version: 1

Effective Time: 20210712