Indications and uses
for the temporary relief of minor aches and pains or as recommended by your doctor ask your doctor about other uses for this product
ASPIRIN
- Manufacturer
- RETAIL BUSINESS SERVICES , LLC.
- Effective date
- 2021-10-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:30:52
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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor 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 81 mg (NSAID)*
* nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- for the temporary relief of minor aches and pains or as recommended by your doctor
- ask your doctor about other uses for this product
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
- 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
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
- 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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
- 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
butylated hydroxytoluene, dextrates, FD&C yellow #6 aluminum lake, flavor, microcrystalline cellulose, modified corn starch, pregelatinized starch, saccharin sodium, stearic acid
PRINCIPAL DISPLAY PANEL
CAREONE®
NDC 72476-105-01
Compare to the active in Bayer® Chewable Aspirin Tablets†
Adult Low Strength
ASPIRIN
81 mg
Pain Reliever (NSAID)
Chewable Orange Flavor
Aspirin Regimen**
Actual Size
36 TABLETS
Products#
Every source-derived product name is available through these pages.
- ASPIRIN
- BUTYLATED HYDROXYTOLUENE
- DEXTRATES
- FD&C YELLOW NO. 6
- ALUMINUM OXIDE
- CELLULOSE, MICROCRYSTALLINE
- MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
- STARCH, PREGELATINIZED CORN
- SACCHARIN SODIUM
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72476-105 | 72476-105-01, 72476-105-03 |
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 |
|---|---|---|---|---|---|---|
| cf22b0e0-1fe9-1af2-e053-2a95a90ad084 | 95bef9ec-c270-707d-e053-2995a90a3574 | 2021-10-24 | Warnings | cf22b0e0-1fe9-1af2-e053-2a95a90ad084 95bef9ec-c270-707d-e053-2995a90a3574 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.