FDA.reportPublic FDA data

Acetaminophen Extra Stength Tablet

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:32:36

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning). adult and children 12 years and over take 2 tablets, every 4 to 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years Ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 don't notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning).

adult and children 12 years and over

  • take 2 tablets, every 4 to 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children under 12 years

Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 20-25 0C (68-77 0F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(866)-562-2756 (Mon - Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen 500mg

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN17
198440acetaminophen 500 MG Oral TabletSCD17
198440APAP 500 MG Oral TabletSY17

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00355289880219(21)L25G53000001(17)271130(10)L25G53GTIN-14: 00355289880219
GTIN-12: 355289880219
UPC-A: 355289880219
EAN-13: 0355289880219
GTIN storage (14 digits): 00355289880219		55289880.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-880-01Acetaminophen100 in 1 BOTTLE, PLASTICTABLET10017
55289-880-06Acetaminophen6 in 1 BOTTLE, PLASTICTABLET617
55289-880-12Acetaminophen12 in 1 BOTTLE, PLASTICTABLET1217
55289-880-20Acetaminophen20 in 1 BOTTLE, PLASTICTABLET2017
55289-880-21Acetaminophen21 in 1 BOTTLE, PLASTICTABLET2117
55289-880-24Acetaminophen24 in 1 BOTTLE, PLASTICTABLET2417
55289-880-30Acetaminophen30 in 1 BOTTLE, PLASTICTABLET3017
55289-880-50Acetaminophen50 in 1 BOTTLE, PLASTICTABLET5017
55289-880-60Acetaminophen60 in 1 BOTTLE, PLASTICTABLET6017
55289-880-97Acetaminophen200 in 1 BOTTLE, PLASTICTABLET20017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-880-01EA - Each55289-8803621471c-519c-4210-a424-75923dbb1b5e12018-02-20
55289-880-06EA - Each55289-8801b164f4d-7a27-471b-a717-0551ba92e9f212021-04-08
55289-880-12EA - Each55289-88037d5d2bb-55da-4df6-b732-b94a7cffc30a12021-04-08
55289-880-20EA - Each55289-88052048397-7c8c-4ea1-96d5-872bd632b8d612019-10-07
55289-880-21EA - Each55289-8807bf835ba-94a6-49b1-b430-cdab47db0b6512026-01-08
55289-880-24EA - Each55289-880ddab36f9-cd9b-48b1-b340-0ccf7d36a2ed12018-02-20
55289-880-30EA - Each55289-88053a6c6a1-52e8-48b7-a2db-9f343f67db2512018-02-20
55289-880-50EA - Each55289-88095999b98-63df-4bc0-979b-cc155dc09fb612021-04-08
55289-880-60EA - Each55289-880863de181-0e5d-4194-913e-aa7b52eaea7412021-04-08
55289-880-97EA - Each55289-880a7d31359-ca89-445e-9ab6-d454707412c412021-04-08
16103-376-06EA - Each16103-376b0ec28db-7535-413e-805f-e1416eeca91812012-07-24
16103-376-08EA - Each16103-376b9284189-e1cd-4f69-88be-fb02466b57ca12012-07-24
16103-376-11EA - Each16103-3767d6a6a6a-b98e-44d2-8664-e2351539d62b12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55289-88055289-880-06, 55289-880-12, 55289-880-20, 55289-880-30, 55289-880-50, 55289-880-60, 55289-880-01, 55289-880-97, 55289-880-24, 55289-880-21
16103-376

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
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
162025-12-16monthly-update2026-06-03 17:46:07

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
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.64696f65-415e-4ce1-a5b3-70662fbcb0022026-01-12WarningsExact identifier
ndc (package): 55289-880-50
ndc (package): 55289-880-30
ndc (package): 55289-880-21
ndc (package): 55289-880-24
ndc (package): 55289-880-01
ndc (package): 55289-880-60
ndc (package): 55289-880-12
ndc (package): 55289-880-97
ndc (package): 55289-880-20
ndc (package): 55289-880-06
ndc (product): 55289-880
ndc11 (package): 55289088050
ndc11 (package): 55289088021
ndc11 (package): 55289088030
ndc11 (package): 55289088060
ndc11 (package): 55289088020
ndc11 (package): 55289088097
ndc11 (package): 55289088006
ndc11 (package): 55289088024
ndc11 (package): 55289088012
ndc11 (package): 55289088001
spl id: 48390181-cda8-a543-e063-6294a90a5896
spl set id: 64696f65-415e-4ce1-a5b3-70662fbcb002
PharbetolACETAMINOPHENPharbest Pharmaceuticals, Inc.04dbd98f-c74d-43b2-8bda-74f18be7cf6c2025-12-24WarningsExact identifier
ndc (product): 16103-376

Reported adverse events (FAERS/openFDA)#

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