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#
Contacts and useful links#
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
Products#
Every source-derived product name is available through these pages.
- ADULT LOW DOSE ASPIRIN
- ASPIRIN
- FD&C YELLOW NO. 6
- ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- SODIUM LAURYL SULFATE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10
- HYPROMELLOSES
- ADULT LOW DOSE ENTERIC COATED ASPIRIN
- METHACRYLIC ACID
- SHELLAC
- SILICON DIOXIDE
- DIMETHICONE
- TRIACETIN
- SODIUM BICARBONATE
- PROPYLENE GLYCOL
- FERROSOFERRIC OXIDE
- POLYDEXTROSE
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-188 | 72189-188-60, 72189-188-30 |
| 72189-187 | 72189-187-60 |
| 72189-274 | 72189-274-60 |
| 16103-356 | |
| 57896-901 | |
| 57896-981 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Aspirin | ASPIRIN | Geri-Care Pharmaceuticals, Corp | 58941782-362d-4436-b365-e909bdbd29a2 | 2026-07-15 | Warnings | 57896-901 |
| Adult Low Dose Aspirin | ASPIRIN | Pharbest Pharmaceuticals, Inc. | 4522f745-b88d-4021-a5dc-0161f1967dc9 | 2025-12-24 | Warnings | 16103-356 |
| Adult Low Dose Enteric Coated Aspirin | ASPIRIN | Geri-Care Pharmaceutical Corp | e327a52a-0e31-44b7-9823-7f60d070ae52 | 2025-04-01 | Warnings | 57896-981 |
| 074b94f1-efea-e265-e063-6294a90ab1ae | c3f2a947-6ca2-d099-e053-2a95a90ac76a | 2023-10-09 | Warnings | c3f2a947-6ca2-d099-e053-2a95a90ac76a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.



