ASPIRIN

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:12

Label at a glance#

ProductASPIRIN
Active ingredientASPIRIN
Label structure17 sections

Indications and uses

temporarily relieves: headache pain and fever of colds toothache menstrual pain muscle pain minor pain of arthritis

Dosage and administration

do not take more than directed 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 unless directed by a doctor children under 12 years: do not use unless directed by a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever/fever reduce

USES

SPL UNCLASSIFIED SECTION

temporarily relieves:

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

WARNINGS 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:

shock
facial swelling
hives
asthma (wheezing)

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 alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

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

ringing in the ears or a loss of hearing occurs
pain gets worse or lasts 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.

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.

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

DIRECTIONS

SPL UNCLASSIFIED SECTION

do not take more than directed
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 unless directed by a doctor
children under 12 years: do not use unless directed by a doctor

OTHER SAFETY INFORMATION

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, polyethylene glycol, propylene glycol

OTC - QUESTIONS SECTION

1-800-645-2158

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 asthma
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic

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

ringing in the ears or a loss of hearing occurs
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

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.

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.

ADVERSE REACTIONS 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

ringing in the ears or a loss of hearing occurs
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
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 unless directed by a doctor
children under 12 years: do not use unless directed by a doctor

INDICATIONS & USAGE SECTION

temporarily relieves: headache - pain and fever of colds - toothache - menstrual pain - muscle pain - minor pain of arthritis

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RFID LabelRFID Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN2
198467aspirin 325 MG Delayed Release Oral TabletSCD2
198467ASA 325 MG Delayed Release Oral TabletSY2
198467aspirin 325 MG Enteric Coated Oral TabletSY2

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
51662-1494-1ASPIRIN100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1494ASPIRIN TABLET, FILM COATED [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, 1 package rows20250503_2553d0cb-3f5c-7ea0-e063-6294a90a3cd4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1054-05EA - Each0536-1054fc237185-1bbd-4a5e-bb81-7af422a69f9112021-06-02
0536-1054-29EA - Each0536-1054cadc1bc8-3468-44a1-9e73-8d4a6d8753e612015-04-03

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
51662-149451662-1494-1
0536-1054

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
ndc (product): 0536-1054
ASPIRINASPIRINHF Acquisition Co LLC, DBA HealthFirst2553d0cb-3f5c-7ea0-e063-6294a90a3cd42025-05-01Warnings, Adverse reactionsExact identifier
ndc (package): 51662-1494-1
ndc (product): 51662-1494
ndc11 (package): 51662149401
spl id: 34184fdf-e74d-fa7f-e063-6294a90a66c3
spl set id: 2553d0cb-3f5c-7ea0-e063-6294a90a3cd4

Reported adverse events (FAERS/openFDA)#

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