Direct Safety Aspirin

Manufacturer
Direct Safety | Unifirst First Aid Corporation | Prestige Packaging
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:13:19

Label at a glance#

ProductDirect Safety Aspirin
Active ingredientASPIRIN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves

■ headache

■ muscle pain

■ toothache

■ menstrual pain

■ pain and fever of colds

■ minor pain of arthritis

WARNINGS SECTION

Warnings

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

■ asthma (wheezing)

■ shock

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

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

OTC - DO NOT USE SECTION

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

■ gout

■ diabetes

■ arthritis

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 occur

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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ drink a full glass of water with each dose

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

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 SECTION

I nactive ingredients

corn starch, hypromellose*, microcrystalline cellulose*, polyethylene glycol* povidone*, propylene glycol*

* may contain

OTC - QUESTIONS SECTION

Questions or comments? 1-800-356-9100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Direct Safety®

Aspirin

Pain Reliever

Aspirin 325 mg (NSAID)

Aspirina 325 mg (AINE)

This Package is for Households without Young Children.

Este Paquete Es Hogares Sin Ninos Pequenos

Industrial Pack 500

(250 Packets of 2 Tablets)

ConneyConney

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Direct Safety®

Aspirin

Pain Reliever

Aspirin 325 mg (NSAID)

Aspirina 325 mg (AINE)

This Package is for Households without Young Children.

Este Paquete Es Hogares Sin Ninos Pequenos

Industrial Pack 500

(250 Packets of 2 Tablets)

116R116R

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
212033aspirin 325 MG Oral TabletPSN7
212033aspirin 325 MG Oral TabletSCD7
212033ASA 325 MG Oral TabletSY7

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61245-620-132023-08-31C16284748780-10191ceaa-6fdb-198a-e063-dbdaa90aec3eDirect Safety Aspirin
61245-620-132023-07-28C16284748780-10191ceaa-6fdb-198a-e063-dbdaa90aec3eDirect Safety Aspirin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61245-616-13Direct Safety Aspirin2 in 1 PACKETTABLET, FILM COATED27
61245-616-13Direct Safety Aspirin250 in 1 BOXTABLET, FILM COATED2507
61245-620-13Direct Safety Aspirin2 in 1 PACKETTABLET, COATED27
61245-620-13Direct Safety Aspirin250 in 1 BOXTABLET, COATED2507

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61245-61661245-616-13
61245-62061245-620-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Direct Safety AspirinASPIRINDirect Safetyba9ba697-d3df-49d7-e053-2a95a90af4062025-09-09WarningsExact identifier
ndc (package): 61245-620-13
ndc (package): 61245-616-13
ndc (product): 61245-620
ndc (product): 61245-616
ndc11 (package): 61245062013
ndc11 (package): 61245061613
spl id: 3e5d77e9-913f-41d7-e063-6294a90a365e
spl set id: ba9ba697-d3df-49d7-e053-2a95a90af406

Reported adverse events (FAERS/openFDA)#

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