FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Safetec of America, Inc.
Effective date
2019-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:54

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 ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets 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 ingredients (in each caplet)

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

SPL UNCLASSIFIED SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may case 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or last more than 10 days
  • 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

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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 the product at controlled room temperature 15°-30°C (59°-86°F).
  • Protect from light, moisture and freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, polyethylene glycol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-800-456-7077

Principal Display Panel – Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DO NOT USE IF POUCH IS TORN OR DAMAGED

Safetec
of America, Inc.

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Principal Display Panel – Pouch Label
Principal Display Panel – Pouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-4406-02024-01-30C16284748780-11030e365-4c87-111a-e063-dadaa90a10e2Drug Facts
61010-4406-12024-01-30C16284748780-11030e365-4c87-111a-e063-dadaa90a10e2Drug Facts
61010-4406-22024-01-30C16284748780-11030e365-4c87-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4406-0Acetaminophen2 in 1 POUCHTABLET22
61010-4406-1Acetaminophen50 in 1 BOXTABLET502
61010-4406-2Acetaminophen100 in 1 BOXTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4406ACETAMINOPHEN TABLET [SAFETEC OF AMERICA, INC.]2Legacy NDC, 3 package rows20200116_67870e7a-88fd-43cf-97e8-cbf546ad4f3f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-440661010-4406-0, 61010-4406-1, 61010-4406-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
hypromellose 2208 (15000 MPA.S)Z78RG6M2N2IACT
polyethylene glycol, unspecified3WJQ0SDW1AIACT
povidone k30U725QWY32XIACT
starch, cornO8232NY3SJIACT
sodium starch glycolate type a potato5856J3G2A2IACT
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
31cf574b-6ae9-40dc-a823-8b48242910ca67870e7a-88fd-43cf-97e8-cbf546ad4f3f2019-12-30WarningsExact identifier
spl id: 31cf574b-6ae9-40dc-a823-8b48242910ca
spl set id: 67870e7a-88fd-43cf-97e8-cbf546ad4f3f

Reported adverse events (FAERS/openFDA)#

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