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NDC 54738-0548-01 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 Richmond Pharmaceuticals, Inc.. 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: 54738-0548-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	54738-0548
Product ID	54738-548_5cc3aaa6-e192-a116-e053-2991aa0a1422
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	Richmond Pharmaceuticals, Inc.
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 54738-0548-01 (54738054801)

Pricing Information	N/A
NDC Package Code	54738-548-01
Billing NDC	54738054801
Package	100 TABLET in 1 BOTTLE (54738-548-01)
Marketing Start Date	2015-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cda8e158-01ac-4c08-826e-4a0c7278e805 Details

Active Ingredient

(in each tablet)

Acetaminophen 325 mg

Purpose

Pain Reliever / Fever Reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

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

Warnings

Liver warning: this product contains acetaminophen. Severe liver damage may occur if

adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
child takes more than 5 tablets 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

do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the 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

adult’s pain gets worse or lasts more than 10 days
child’s pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
any new symptoms appear

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

Overdose warning:Taking more than the recommended dose may cause liver damage. In case of overdose contact Poisom Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs of symptoms.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center 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

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

Other Information

store at 15-30 °C (59-86 °F)

Inactive Ingredients

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

Questions or Comments

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

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

PRINCIPAL DISPLAY PANEL

NDC- 54738-548-01... 100 APAP 325MG TABS

NDC- 54738-548-03... 1000 APAP 325MG TABS

NDC- 54738-548-50... 50 APAP 325MG TABS

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-548
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
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AP;012
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54738-548-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015
2	NDC:54738-548-03	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015
3	NDC:54738-548-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	05/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-548)

Revised: 10/2017

Document Id: 5cc3aaa6-e192-a116-e053-2991aa0a1422

Set id: cda8e158-01ac-4c08-826e-4a0c7278e805

Version: 2

Effective Time: 20171030