FDA.reportPublic FDA data

Acetaminophen USP 325 mg Tablets

Manufacturer
Proficient Rx LP
Effective date
2025-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:41:24

Label at a glance#

ProductACETAMINOPHEN 325 MG
Active ingredientACETAMINOPHEN
Label structure19 sections

Indications and 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

Dosage and administration

• 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

Storage and handling

• store at 15° to 30°C (59° to 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTHER SAFETY INFORMATION

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.

OTC - DO NOT USE 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN 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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • store at 15° to 30°C (59° to 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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®

71205-456-30
71205-456-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN5
313782acetaminophen 325 MG Oral TabletSCD5
313782APAP 325 MG Oral TabletSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371205456306GTIN-13: 0371205456306
EAN-13: 0371205456306
GTIN-12: 371205456306
UPC-A: 371205456306
GTIN storage (14 digits): 00371205456306		image-01.jpg
Data codeData Matrix010037120545630621MASTER<GS>171000000image-01.jpg
Data codeData MatrixQA045630*71205-456-30*#30*00000*69618-0010-01*000000*MASTERimage-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-456-00ACETAMINOPHEN 325 MG100 in 1 BOTTLE, PLASTICTABLET1005
71205-456-30ACETAMINOPHEN 325 MG30 in 1 BOTTLE, PLASTICTABLET305
71205-456-60ACETAMINOPHEN 325 MG60 in 1 BOTTLE, PLASTICTABLET605
71205-456-90ACETAMINOPHEN 325 MG90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-456-30EA - Each71205-45653c80524-18b7-4929-810f-ee7fee59cb3612022-06-06
69618-010-01EA - Each69618-010e4afc635-7f91-4104-9fae-ea9ec25546cd12016-01-13
69618-010-10EA - Each69618-010c4fcdc23-5064-4fc1-82e0-bc730c66709512016-01-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71205-45671205-456-30, 71205-456-60, 71205-456-90, 71205-456-00
69618-010

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-02-01full-release2026-06-01 00:08:52

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN 325 MGACETAMINOPHENProficient Rx LP6794830a-7856-464d-84be-c8b253cf41ac2025-10-01WarningsExact identifier
ndc (package): 71205-456-30
ndc (package): 71205-456-00
ndc (package): 71205-456-90
ndc (package): 71205-456-60
ndc (product): 71205-456
ndc11 (package): 71205045660
ndc11 (package): 71205045630
ndc11 (package): 71205045600
ndc11 (package): 71205045690
spl id: d25dcece-12ac-4e85-a6ec-fd71d1dc1fde
spl set id: 6794830a-7856-464d-84be-c8b253cf41ac
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
ndc (product): 69618-010

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.