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NDC 00904-6719-80 Acetaminophen 325 mg/1 Details

Acetaminophen 325 mg/1

Acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. 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: 00904-6719-80
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00904-6719
Product ID	0904-6719_4612b5f6-4120-4364-a6f8-b43d15d0caf8
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	325
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-6719-80 (00904671980)

Pricing Information
NDC Package Code	0904-6719-80
Billing NDC	00904671980
Package	1000 TABLET in 1 BOTTLE (0904-6719-80)
Marketing Start Date	2018-12-31
NDC Exclude Flag	N
Price Per Unit	0.02082
Pricing Unit	EA
Effective Date	2022-05-18
NDC Description	ACETAMINOPHEN 325 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-06-01

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 5483b704-88c0-4176-a04c-f8b2b85e8c57 Details

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

•: temporarily relieves minor aches and pains due to:
•: headache
•: muscular aches
•: backache
•: 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 of acetaminophen 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

•: 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 the user has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user

•: has liver disease
•: is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

•: pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
•: fever gets worse or lasts more than 3 days
•: new symptoms occur
•: 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 (see overdose warning)

	adults and children 12 years and over	• take 2 tablets every 4 to 6 hours while symptoms last • do not take more than 10 tablets in 24 hours • do not use for more than 10 days unless directed by a doctor
	children 6-11 years	• take 1 tablet every 4 to 6 hours while symptoms last • do not take more than 5 tablets in 24 hours • do not use for more than 5 days unless directed by a doctor
	children under 6 years	ask a doctor

Inactive ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid

*may contain this ingredient

Questions or comments?

1-800-616-2471

Principal Display Panel

Compare to the active ingredient in Regular Strength Tylenol® Tablets

Acetaminophen

Pain Reliever/Fever Reducer

Aspirin-Free

Regular Strength

TABLETS

50 ACETAMINOPHEN TABLETS – 325 mg. EACH

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6719
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (beveled edge)	Size	10mm
Flavor		Imprint Code	325MG;L403
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-6719-50	1 in 1 CARTON	10/18/2018
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0904-6719-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2018
3	NDC:0904-6719-80	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	10/18/2018

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2019

Document Id: 4612b5f6-4120-4364-a6f8-b43d15d0caf8

Set id: 5483b704-88c0-4176-a04c-f8b2b85e8c57

Version: 3

Effective Time: 20190117