Indications and uses
temporarily relieves: headache muscle pain toothache menstrual pain pain and fever of colds minor pain of arthritis
Aspirin
- Manufacturer
- Harmon Stores Inc.
- Effective date
- 2024-10-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:51:50
Label at a glance#
ProductAspirin
Active ingredientASPIRIN
Label structure9 sections
Dosage and administration
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
Storage and handling
store between 20°-25°C (68°-77°F) in a dry place retain carton for complete product information and warnings
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID) *
* nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves:
- headache
- muscle pain
- toothache
- menstrual pain
- pain and fever of colds
- minor pain of arthritis
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
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
OTC - DO NOT USE SECTION
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
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:
- diabetes
- gout
- 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
- pain gets worse or lasts for more than 10 days
- redness or swelling is present
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- ringing in the ears or loss of hearing occurs
These could be signs of a serious condition.
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 (1-800-222-1222).
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 information
- store between 20°-25°C (68°-77°F) in a dry place
- retain carton for complete product information and warnings
Inactive ingredients
corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide
PRINCIPAL DISPLAY PANEL
CORE VALUES
Compare to the active ingredient in Bayer® Aspirin
Regular Strength
SAFE PAIN RELIEF
Aspirin
Consult your healthcare provider before using this product for your heart.
PAIN RELIEVER / FEVER REDUCER (NSAID)
ACTUAL SIZE
100 COATED TABLETS 325 MG EACH
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Aspirin
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE, UNSPECIFIED
- CELLULOSE, MICROCRYSTALLINE
- MINERAL OIL
- STARCH, CORN
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63940-320 | 63940-320-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 24c68861-fc91-4f74-e063-6394a90a16dd | 219ca3f4-24ad-470c-8482-6606d6c4bc85 | 2024-10-18 | Warnings | 24c68861-fc91-4f74-e063-6394a90a16dd 219ca3f4-24ad-470c-8482-6606d6c4bc85 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.