First Aid Only Aspirin Tablets

Manufacturer
Acme United Corporation
Effective date
2018-03-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:00:34

Label at a glance#

ProductFirst Aid Only Aspirin
Active ingredientASPIRIN
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains associated with headache minor arthritis common cold menstrual cramps muscular aches backache toothache Temporarily reduces fever.

Dosage and administration

do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Do not give to children under 12 years of age.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains associated with

  • headache
  • minor arthritis
  • common cold
  • menstrual cramps
  • muscular aches
  • backache
  • toothache

Temporarily reduces fever.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy Alert: aspirin may cause a severe allergic reaction which may include:

•hives •facial swelling •shock •asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription
    NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcohol drinks every day while
    using this product
  • take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

  • If you are allergic to aspirinor any other pain reliever/fever reducer

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking prescription drugs for gout, diabetes or arthritis

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • if ringing in the ears or loss of hearing occurs
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • an allergic reaction occurs. Seek medical help right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless
    directed by a doctor (see Warnings)
  • drink a full glass of water with each dose

Adults and children: (12 years and older)

SPL UNCLASSIFIED SECTION

Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years:

SPL UNCLASSIFIED SECTION

Do not give to children under 12 years of age.

Other information

SPL UNCLASSIFIED SECTION

  • read all product information before using
  • store at room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-835-2263

First Aid Only Aspirin Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Only Label First Aid Only Aspirin LabelFirst Aid Only Aspirin Label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-02040924-0204-01
47682-097

Ingredients#

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

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

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
28623357-59e7-08bf-e063-6394a90a476f6869dcc1-2406-4007-e053-2991aa0a4b2c2024-12-03WarningsExact identifier
spl set id: 6869dcc1-2406-4007-e053-2991aa0a4b2c

Reported adverse events (FAERS/openFDA)#

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