FDA.reportPublic FDA data

ACETAMINOPHEN

Manufacturer
Akron Pharma Inc.
Effective date
2021-07-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:21

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

To reduce fever and for the temporary relief of minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps. Temporarily reduces fever.

Dosage and administration

 adults & children 12 years and over  take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours do not use for more than 10 days unless directed by a doctor  child under 12 years  ask a doctor

Storage and handling

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

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

To reduce fever and for the temporary relief of minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and 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 of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours 
  • 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

OTC - DO NOT USE SECTION

  • 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.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the user has

OTC - ASK DOCTOR SECTION

  • has liver disease
  • is a child with pain of arthritis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is 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 (for adults) or 5 days (for 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.(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.

Directions - do not take more than directed (see overdose warning)

DOSAGE & ADMINISTRATION SECTION

 adults & children 12 years and over
  •  take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
 child under 12 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

pregelatinized starch, microcrystalline cellulose, povidone (PVP K-30), colloidal silicon dioxide, croscarmellose sodium, stearic acid.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-225-6999

Manufactured for
Akron Pharma, Inc.,

373 RT US46 W Building E,

Suite 117, Fairfeld, NJ - 07004

* This product is not manufactured or distributed by McNeal Consumer Healthcare, Owner of registered trademark Tylenol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500mg-100ct500mg-100ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-8027-12023-01-30C16284748780-1f386c649-a543-0266-e053-dadaa90a7c1aAcetaminophen 500 mg Extra Strength
71399-8027-22023-01-30C16284748780-1f386c649-a543-0266-e053-dadaa90a7c1aAcetaminophen 500 mg Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8027-1ACETAMINOPHEN100 in 1 BOTTLETablet1001
71399-8027-2ACETAMINOPHEN1000 in 1 BOTTLETablet10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8027ACETAMINOPHEN (ACETAMINOPHEN EXTRA STRENGTH) TABLET [AKRON PHARMA INC.]1Legacy NDC, 2 package rows20210711_4631df61-00a7-4ea8-849b-7b28ea36e41b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8027-1EA - Each71399-8027277742b3-2c46-4e52-af20-ff01f9f5ca1512021-12-08
71399-8027-2EA - Each71399-8027d6e577c7-2026-42f3-8ae6-045d5e08f07312021-12-08

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-802771399-8027-1, 71399-8027-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PROPYLPARABENZ8IX2SC1OHIACT
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b1bf8ea6-c717-4ff7-b2b3-b1265ce6cff54631df61-00a7-4ea8-849b-7b28ea36e41b2021-07-05WarningsExact identifier
spl id: b1bf8ea6-c717-4ff7-b2b3-b1265ce6cff5
spl set id: 4631df61-00a7-4ea8-849b-7b28ea36e41b

Reported adverse events (FAERS/openFDA)#

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