OTC - ACTIVE INGREDIENT SECTION
Active Ingredient in Each tablet
Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug
Active Ingredient in Each tablet
Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug
Ask a doctor before use if: stomach bleeding waring 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, you have not been drinking fluids, you have lost a lot of fluid due to vomiting or diarrhea
Uses: temporarily relieves minor aches and pains: for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
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, 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 non-prescription 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.
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
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
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, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, any new symptoms appear
If pregnant or breast-feeding, ask a health profession 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
Inactive ingredients: 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 sulfate, talc, titanium dioxide
Uses - temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
Available over bagged with 10 tablets per bag, NDC 55154-1494-0
Distributed By:
Cardinal Health
Dublin, OH 43017
L48271500818
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55154-1494-0 | EA - Each | 55154-1494 | c5066457-aafc-45b8-af94-1b72cc1775b2 | 1 | 2020-01-03 |
| 63739-522-01 | EA - Each | 63739-522 | 09e48c54-8429-482c-89be-526c85ebe7e4 | 1 | 2014-05-02 |
| 63739-522-10 | EA - Each | 63739-522 | 1150c441-ccee-4a09-bcd7-81c75ba88c15 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| aspirin | ACTIVE INGREDIENT | R16CO5Y76E | 3 | |
| aspirin | ACTIVE MOIETY | R16CO5Y76E | 3 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | 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 | |
| IRON | INACTIVE INGREDIENT | E1UOL152H7 | 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 |
|---|---|
| 55154-1494 | 55154-1494-0 |
| 63739-522 |
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 |
|---|---|---|---|---|---|---|
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | OINTMENT / TOPICAL | 0.1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / BUCCAL | 5.18 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAOCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRASYNOVIAL | ADJ PH | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / SUBLINGUAL | 0.08 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | CAPSULE, DELAYED RELEASE / ORAL | 1321 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / SUBLINGUAL | 1.1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | ADJ PH | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 1494 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / ORAL | 2 mg/5ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / TOPICAL | 0.2 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, METERED / RESPIRATORY (INHALATION) | ADJ PH | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 570 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | FILM / BUCCAL | 0.09 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / OPHTHALMIC | ADJ PH | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CONCENTRATE / ORAL | 1 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| anhydrous lactose | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / BUCCAL | 48 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION, EXTENDED RELEASE / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING / ORAL | 16 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GRANULE / ORAL | 12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EXTENDED RELEASE / ORAL | 320 mg | ||
| triethyl citrate | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, DELAYED RELEASE / ORAL | 120 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, DELAYED RELEASE / ORAL | 1.9 mg | ||
| anhydrous lactose | ANHYDROUS LACTOSE | 3SY5LH9PMK | CAPSULE, DELAYED RELEASE / ORAL | 360 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | POWDER / ORAL | 66 mg | ||
| triethyl citrate | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 7 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 |
|---|---|---|---|---|---|---|
| c849b737-6d90-44da-b945-1e6e9d35195b | 325d6dd2-7d89-498a-a700-8715693ad80f | 2020-05-21 | Warnings | c849b737-6d90-44da-b945-1e6e9d35195b 325d6dd2-7d89-498a-a700-8715693ad80f |
Adverse event summaries are temporarily unavailable. Other product information remains available.