Indications and uses
temporarily relieves minor aches and pains
Leader Aspirin
- Manufacturer
- Cardinal Health 110, LLC. dba Leader
- Effective date
- 2021-06-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:43:08
Label at a glance#
ProductLeader Aspirin
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 4 to 8 tablets every 4 hours not to exceed 48 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 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
temporarily relieves minor aches and pains
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
Do not use
- if you have ever had an allergic reaction to any pain reliever/fever reducer
- for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
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 gout, diabetes or 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
- fever gets worse or lasts for more than 3 days
- ringing in the ears or loss of hearing occurs
- redness or swelling is present
- new symptoms occur
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 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 4 to 8 tablets every 4 hours not to exceed 48 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 20-25°C (68-77°F)
Inactive ingredients
corn starch, dextrose excipient, FD&C yellow #6 aluminum lake, flavors, saccharin sodium
Questions or comments?
1-800-719-9260
Principal Display Panel
Orange Flavor
Aspirin
81 mg Tablets | Pain Reliever (NSAID)
Adult Aspirin Regimen
Talk to your doctor or other healthcare provider before using this product for your heart.
Actual Size
COMPARE TO ST. JOSEPH® 81 mg LOW DOSE ASPIRIN active ingredient
36 CHEWABLE TABLETS
100% Money Back Guarantee
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0170-1 | EA - Each | 70000-0170 | 9fccacfb-c4f3-4c79-b4d1-889656cf2b71 | 1 | 2017-12-14 |
Products#
Every source-derived product name is available through these pages.
- Leader Aspirin
- Aspirin
- STARCH, CORN
- FD&C YELLOW NO. 6
- SACCHARIN SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0170 | 70000-0170-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
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 |
|---|---|---|---|---|---|---|
| 46a76f93-1dca-4ed1-a3a0-bbe3e9aa1b92 | a4a750da-47dc-430a-90e2-284dce6cdeaa | 2021-06-21 | Warnings | 46a76f93-1dca-4ed1-a3a0-bbe3e9aa1b92 a4a750da-47dc-430a-90e2-284dce6cdeaa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.