Indications and uses
temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
Pain Reliever - Aspirin Delayed Release Tablets, 81 mg
- Manufacturer
- HealthLife Of USA | Elysium Pharmaceutical Ltd. | Health Pharma USA LLC
- Effective date
- 2023-11-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:19:21
Label at a glance#
ProductPain Reliever
Active ingredientASPIRIN
Label structure10 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 while symptoms last; do not take more than 48 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor
Storage and handling
store at room temperature 15-30ºC (59-86ºF) read all product information before using. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each caplet) Purpose
Aspirin 81 mg (NSAID)* ........................................ Pain reliever
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
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
- shock
- facial swelling
- 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 are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if
- you have asthma
- 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
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- under a doctor's care for any serious condition
- taking any other drug
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs.
Seek medical help right away.
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling present in the painful area
- new symptoms occur
These could be sign 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 while symptoms last; do not take more than 48 tablets in 24 hours unless directed by a doctor
- children under 12 years:ask a doctor
Other information
- store at room temperature 15-30ºC (59-86ºF)
- read all product information before using.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive ingredients
May Contains:
Starch, Povidone, Microcrystalline cellulose, Crosscarmellose Sodium, Stearic Acid, Colloidal Sillicon Dioxide, Methacrylic acid copolymer and ethyl acrylate co-polymer, Triethyl Citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow#6.
Questions or comments?
Call 1-844-832-1138
9AM – 5PM EST Monday - Friday
PRINCIPAL DISPLAY PANEL
See New Warnings Information & Directions
Compare to Bayer ®Low Dose Aspirin active ingredients †
†This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer ®Low Dose Aspirin.
Aspirin Delayed Release Tablets, 81 mg
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Pain Reliever
- Aspirin 81 mg
- STARCH, CORN
- POVIDONE
- MICROCRYSTALLINE CELLULOSE
- CROSCARMELLOSE SODIUM
- STEARIC ACID
- SILICON DIOXIDE
- METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
- TRIETHYL CITRATE
- TALC
- TITANIUM DIOXIDE
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- ASPIRIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69517-104 | 69517-104-25, 69517-104-50, 69517-104-02, 69517-104-30, 69517-104-65, 69517-104-01, 69517-104-60, 69517-104-03, 69517-104-05, 69517-104-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER | NX76LV5T8J | IACT |
| TRIETHYL CITRATE | 8Z96QXD6UM | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | 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 |
|---|---|---|---|---|---|---|
| 36c2b9e6-86b8-dc91-e063-6394a90a5b9c | f0ce670a-179a-462c-ad4f-02129c456ffb | 2025-06-04 | Warnings | f0ce670a-179a-462c-ad4f-02129c456ffb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.