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NDC 71205-0456-00 ACETAMINOPHEN 325 MG 325 mg/1 Details

ACETAMINOPHEN 325 MG 325 mg/1

ACETAMINOPHEN 325 MG is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 71205-0456-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	71205-0456
Product ID	71205-456_c6aae2d7-e737-43f0-b9a9-4fd1d9662f6e
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 325 MG
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	Proficient Rx LP
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 71205-0456-00 (71205045600)

Pricing Information	N/A
NDC Package Code	71205-456-00
Billing NDC	71205045600
Package	100 TABLET in 1 BOTTLE, PLASTIC (71205-456-00)
Marketing Start Date	2020-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6794830a-7856-464d-84be-c8b253cf41ac Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP, 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 or 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, 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 while using this product

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Ask a doctor before use if the user has liver disease

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

SPL UNCLASSIFIED SECTION

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
•: 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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 4-6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years	take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 years	do not use

Other information

•: store at 15° to 30°C (59° to 86°F)

Inactive ingredients

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

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC 71205-456-30

Regular Strength

Acetaminophen USP 325 mg

PAIN RELIEVER

FEVER REDUCER

30 TABLETS

*Compare to Active Ingredient in Regular Strength TYLENOL®

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 325 MG

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-456(NDC:69618-010)
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)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AP;012
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-456-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2022
2	NDC:71205-456-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2022
3	NDC:71205-456-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2022
4	NDC:71205-456-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/01/2015

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-456) , RELABEL(71205-456)

Revised: 11/2022

Document Id: c6aae2d7-e737-43f0-b9a9-4fd1d9662f6e

Set id: 6794830a-7856-464d-84be-c8b253cf41ac

Version: 3

Effective Time: 20221101

Search by Drug Name or NDC

NDC 71205-0456-00 ACETAMINOPHEN 325 MG 325 mg/1 Details

ACETAMINOPHEN 325 MG 325 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71205-0456-00 (71205045600)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6794830a-7856-464d-84be-c8b253cf41ac Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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