Indications and uses
For temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
For temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
Drink with 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 at 15°-30°C (59°-86°F). Do not use if imprinted seal under cap is missing or damaged.
Aspirin 81 mg (NSAID) nonsteroidal anti-inflammatory drug
Pain reliever.
For temporary relief of minor aches and pains or as recommended by your doctor.
Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
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.
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.
Before use if you are taking a prescription drug for:
gout
diabetes
arthritis
And ask a doctor if:
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,
allergic reaction occurs seek medical help right away,
pain gets worse or lasts more than 10 days,
redness or swelling is present,
new symptoms occur,
ringing in the ears or loss of hearing occurs.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Drink with 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 at 15°-30°C (59°-86°F). Do not use if imprinted seal under cap is missing or damaged.
Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide, triethyl citrate.
.
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11534-155-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d910-f424-e053-dadaa90a57ce | Aspirin 81 mg Pain reliever |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11534-155-11 | Aspirin | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | 3 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 3 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 3 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 3 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11534-155 | 11534-155-11 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SPRAY / TOPICAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / BUCCAL | 5.18 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 4739 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRALESIONAL | 4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, SOLUTION / INTRAVENOUS | 0.45 %w/v | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, DELAYED RELEASE / ORAL | 120 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING / ORAL | 16 mg | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 5.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAMUSCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED PELLETS / ORAL | 135.2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER / INTRAVENOUS | ADJ PH | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / RECTAL | 20 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IONTOPHORESIS | ADJ PH | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRASYNOVIAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LOTION / TOPICAL | 15 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 900 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SYRUP / ORAL | 4 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SOLUTION / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAMUSCULAR | 176 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRALESIONAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBMUCOSAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / VAGINAL | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | DROPS / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / TOPICAL | 0.98 %w/w | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | ELIXIR / ORAL | 0.3 mg/15ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 8 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg |
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 |
|---|---|---|---|---|---|---|
| 5fdaba26-4c64-4896-a89a-69fefec6e563 | eae5797a-0f4d-4b80-bd48-2445c2b74b25 | 2011-01-10 | Warnings | 5fdaba26-4c64-4896-a89a-69fefec6e563 eae5797a-0f4d-4b80-bd48-2445c2b74b25 |
Adverse event summaries are temporarily unavailable. Other product information remains available.