Indications and uses
temporarily relieves minor aches and pains due to: minor pain from arthritis headache menstrual pain toothache muscle pain a cold or as recommended by your doctor
Leader 44-227
- Manufacturer
- Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
- Effective date
- 2026-09-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 13
- Source
- daily-update
- Hydrated at
- 2026-09-05 01:01:15
Label at a glance#
ProductAspirin Regular Strength
Active ingredientASPIRIN
Label structure9 sections
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 to 2 tablets every 4 hours while symptoms last do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pains due to:
- minor pain from arthritis
- headache
- menstrual pain
- toothache
- muscle pain
- a cold
- or as recommended by your doctor
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:
- facial swelling
- hives
- shock
- 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 have ever had an allergic reaction to 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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- diabetes
- arthritis
- gout
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 loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
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
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last
- do not take more than 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
Other 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 ingredients
black iron oxide, cellulose, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate
Questions or comments?
1-800-426-9391
Principal display panel
LEADER™
NDC 70000-0035-1
Regular Strength
Aspirin
Tablets, 325 mg
Pain Reliever (NSAID)
For the Temporary Relief
from Minor Arthritis Pain
COMPARE TO
ECOTRIN®
REGULAR STRENGTH
active ingredient†
100% Money Back Guarantee
125 ENTERIC COATED
TABLETS
Actual Size
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0096295138085 | GTIN-13: 0096295138085 EAN-13: 0096295138085 GTIN-12: 096295138085 UPC-A: 096295138085 GTIN storage (14 digits): 00096295138085 | leader-44-227-1.jpg |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0035-1 | EA - Each | 70000-0035 | 61dcc8df-1e54-4139-a7b3-d888f2cc0333 | 1 | 2020-01-03 |
Products#
Every source-derived product name is available through these pages.
- Aspirin Regular Strength
- Aspirin
- FERROSOFERRIC OXIDE
- POWDERED CELLULOSE
- SILICON DIOXIDE
- D&C YELLOW NO. 10 ALUMINUM LAKE
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- HYPROMELLOSE, UNSPECIFIED
- METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- PROPYLENE GLYCOL
- SHELLAC
- DIMETHICONE
- WATER
- SODIUM BICARBONATE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0035 | 70000-0035-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 12 | 2025-12-08 | full-release | 2026-06-01 01:20:51 |
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 Regular Strength | ASPIRIN | Cardinal Health 110, LLC. DBA Leader | 2777beea-06d7-4ff5-ae4a-ad7a117dfb62 | 2026-09-02 | Warnings | 70000-0035-1 70000-0035 70000003501 38f5cff9-33ed-4cd5-a99f-b84a07ab9982 2777beea-06d7-4ff5-ae4a-ad7a117dfb62 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.