FDA.reportPublic FDA data

First Aid Only Extra-Strength Non-Aspirin

Manufacturer
Acme United Corporation
Effective date
2018-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:00:29

Label at a glance#

ProductFirst Aid Only Extra-Strength Non-Aspirin
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains associated with headache toothache minor arthritis pain muscular aches common cold menstrual cramps temporarily reduces fever

Dosage and administration

do not use more than directed Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with

  • headache
  • toothache
  • minor arthritis pain
  • muscular aches
  • common cold
  • 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 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

SPL UNCLASSIFIED SECTION

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • pain or fever persists or gets worse
  • new symptoms occur
  • redness or swelling is present
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

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 use more than directed

Adults and children: (12 years and older)

SPL UNCLASSIFIED SECTION

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

SPL UNCLASSIFIED SECTION

Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may

cause liver damage.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* May contain

OTC - QUESTIONS SECTION

Questions? 1-800-835-2263

First Aid Only Extra-Strength Non-Aspirin Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Only Extra-Strength Non-Aspirin Label

First Aid Only Extra-Strength Non-Aspirin LabelFirst Aid Only Extra-Strength Non-Aspirin Label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-02280924-0228-01
47682-125

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYPROMELLOSES3NXW29V3WOIACT
MALTODEXTRIN7CVR7L4A2DIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
286211fc-86d0-ddf5-e063-6394a90a8b0e6891f5ee-6879-7d10-e053-2a91aa0a3aae2024-12-03WarningsExact identifier
spl set id: 6891f5ee-6879-7d10-e053-2a91aa0a3aae

Reported adverse events (FAERS/openFDA)#

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