ASPIRIN

Manufacturer
DIRECT RX
Effective date
2023-06-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:29:26

Label at a glance#

ProductADULT LOW DOSE ASPIRIN
Active ingredientASPIRIN
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain Reliever

OTC - WHEN USING SECTION

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
ask your doctor about other uses for this product

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:

hives
asthma (wheezing)
facial swelling
shock

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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

the 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 have asthma
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:

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

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 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.

Keep out of reach of children.

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

OTC - QUESTIONS SECTION

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not to exceed 48 tablets in 24 hours or as directed by a physician
children under 12 years: consult a physician

OTHER SAFETY INFORMATION

Tamper Evident: Do not use if safety seal under cap is broken or missing
store at room temperature (15°-30°C)
avoid excess heat and moisture

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow# 10 lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.

OTC - QUESTIONS SECTION

(866) 562-2756

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

188188

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

187187

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

274274

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-188-3072189-188-30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-188-30EA - Each72189-18809092793-159a-4ec2-9b3f-c27e84424d4512022-07-06
72189-188-60EA - Each72189-1888b7ec441-d92b-4f8c-ab82-1afca17946b712021-07-15
72189-187-60EA - Each72189-1873042bc4f-a9ed-45b4-8324-6b3d1ef3dd6d12021-07-15
72189-274-60EA - Each72189-27429d6ff31-1bea-4745-8479-1912001fcb2112021-10-08
16103-356-09EA - Each16103-3562a4fc101-b4b3-4006-94da-4dcc4f99468a12012-07-24
16103-356-11EA - Each16103-3565401e9c5-7206-4514-b71f-0844577ed8af12012-07-24
57896-901-01EA - Each57896-90104fcb1c0-536e-42ab-945c-7e0952d9932712014-11-05
57896-901-10EA - Each57896-901dd688c70-e3dc-41ed-b240-685e4ace336b12014-11-05
57896-981-01EA - Each57896-981a27fc58c-b6ba-404b-8692-81e83053868712013-02-13
57896-981-10EA - Each57896-9812ba797b8-4f6d-47a9-a1e6-1cfc7031fa1c12017-05-04
57896-981-12EA - Each57896-981f0f0d829-ac3d-4cea-bf55-9166def6b6f012016-03-04
57896-981-20EA - Each57896-98181ff5719-941d-4fe2-9cd5-77089991cde912022-03-09
57896-981-30EA - Each57896-981641fb666-6519-46d4-ae60-d435b7c86c1e12018-11-06

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINGeri-Care Pharmaceuticals, Corp58941782-362d-4436-b365-e909bdbd29a22026-07-15WarningsExact identifier
ndc (product): 57896-901
Adult Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.4522f745-b88d-4021-a5dc-0161f1967dc92025-12-24WarningsExact identifier
ndc (product): 16103-356
Adult Low Dose Enteric Coated AspirinASPIRINGeri-Care Pharmaceutical Corpe327a52a-0e31-44b7-9823-7f60d070ae522025-04-01WarningsExact identifier
ndc (product): 57896-981
074b94f1-efea-e265-e063-6294a90ab1aec3f2a947-6ca2-d099-e053-2a95a90ac76a2023-10-09WarningsExact identifier
spl set id: c3f2a947-6ca2-d099-e053-2a95a90ac76a

Reported adverse events (FAERS/openFDA)#

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