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NDC 00904-6773-61 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: 00904-6773-61
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00904-6773
Product ID	0904-6773_a49aada7-a48b-48c4-e053-2a95a90ab53c
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 00904-6773-61 (00904677361)

Pricing Information
NDC Package Code	0904-6773-61
Billing NDC	00904677361
Package	10 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6773-61) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	2018-10-23
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 780aad35-d0f1-44b1-e053-2991aa0af9a7 Details

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

SPL UNCLASSIFIED SECTION

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

headache 
muscular aches 
backache 
minor pain of arthritis
common cold 
toothache 
premenstrual and menstrual cramps

SPL UNCLASSIFIED SECTION

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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, which is the maximum daily amount
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 you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if 

pain gets worse or lasts more than 10 days in adults 
pain gets worse or lasts more than 5 days in children under 12 years
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. This Unit Dose package is not child

resistant and is Intended for Institutional Use Only.

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, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 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

Other information

store at room temperature

SPL UNCLASSIFIED SECTION

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

(800) 616-2471

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Distributed By: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

PRINCIPAL DISPLAY PANEL

NDC 0904-6773-61

MAJOR

Unit Dose

Acetaminophen

Regular Strength Tablets

325 mg

100 Tablets

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6773
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
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;220
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-6773-61	10 in 1 BOX, UNIT-DOSE	10/23/2018
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	10/23/2018

Labeler - Major Pharmaceuticals (191427277)

Revised: 5/2020

Document Id: a49aada7-a48b-48c4-e053-2a95a90ab53c

Set id: 780aad35-d0f1-44b1-e053-2991aa0af9a7

Version: 3

Effective Time: 20200501

Search by Drug Name or NDC

NDC 00904-6773-61 Acetaminophen 325 mg/1 Details

Acetaminophen 325 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00904-6773-61 (00904677361)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 780aad35-d0f1-44b1-e053-2991aa0af9a7 Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

SPL UNCLASSIFIED SECTION

Do not use 

Overdose warning

Directions

Other information

SPL UNCLASSIFIED SECTION

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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