Aspirin

Manufacturer
Wildman Business Group | LNK International, Inc. | Medique Products | Prestige Packaging
Effective date
2024-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:32

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Aspirin325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves

  • headache
  • muscle pain
  • minor pain of arthritis
  • pain and fever of colds
  • toothache
  • menstrual pain

WARNINGS

WARNINGS SECTION

Warnings

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.

SPL UNCLASSIFIED SECTION

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

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

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

Stomach bleeding warning:

SPL UNCLASSIFIED SECTION

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

Do not use if you are allergic to aspirin or to any other pain reliever/fever reducer

ASK DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • 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 DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • 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 lasts more than 3 days
  • if ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • new symptoms appear

PREGNANCY OR BREAST FEEDING

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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

  • drink a full glass of water with each dose

SPL UNCLASSIFIED SECTION

Adults and children: (12 years and over) Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.

SPL UNCLASSIFIED SECTION

Children under 12 years: Consult a doctor

OTHER SAFETY INFORMATION

Other information

  • store at room temperature
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

QUESTIONS

OTC - QUESTIONS SECTION

Questions or comments? (888) 602-0288

Principal Display Panel – 250 Tablet Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2501

5 GRAIN

ASPIRIN

Pull to Open

For Temporary Relief of Minor Aches and Pains

The Provision

First Aid

Line™

BY WILDMAN

250 Tablets

2 Per Packet

Figure
Figure

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN1
198467aspirin 325 MG Delayed Release Oral TabletSCD1
198467ASA 325 MG Delayed Release Oral TabletSY1
198467aspirin 325 MG Enteric Coated Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84269-2501-1Aspirin2 in 1 PACKETTABLET, COATED21
84269-2501-1Aspirin50 in 1 BOXTABLET, COATED501
84269-2501-2Aspirin2 in 1 PACKETTABLET, COATED21
84269-2501-2Aspirin125 in 1 BOXTABLET, COATED1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84269-2501ASPIRIN TABLET, COATED [WILDMAN BUSINESS GROUP]1Current NDC, 4 package rows20240701_cdbfcf14-8685-40a9-9778-a3b4329dc1ad.zip

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
84269-250184269-2501-2, 84269-2501-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
AspirinASPIRINWildman Business Groupcdbfcf14-8685-40a9-9778-a3b4329dc1ad2024-07-01WarningsExact identifier
ndc (package): 84269-2501-1
ndc (package): 84269-2501-2
ndc (product): 84269-2501
ndc11 (package): 84269250101
ndc11 (package): 84269250102
spl id: ed8ff9d9-1cf9-4cd3-8a96-6440a5f3ef17
spl set id: cdbfcf14-8685-40a9-9778-a3b4329dc1ad

Reported adverse events (FAERS/openFDA)#

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