Indications and uses
Temporarily relieves minor aches and pains.
Aspirin
- Manufacturer
- Bedrock Brands, LLC (ST. JOSEPH)
- Effective date
- 2014-07-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:35:49
Label at a glance#
ProductAspirin
Active ingredientASPIRIN
Label structure10 sections
Dosage and administration
drink a full glass of water with each dose adults and children 12 years of age and over : take 4 to 8 tablets every 4 hours while symptoms persist do not exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years of age : do not use unless directed by a doctor
Storage and handling
store at controlled room temperature 20º-25ºC (68º-77ºF)
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
- 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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- 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
- 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 have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
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.
- new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- ringing in the ears or a loss of hearing occurs
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 of age and over: take 4 to 8 tablets every 4 hours while symptoms persist
- do not exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years of age: do not use unless directed by a doctor
Other information
- store at controlled room temperature 20º-25ºC (68º-77ºF)
Inactive ingredients
FD&C red #40, FD&C yellow #6, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, triethyl citrate
Questions or comments?
Call toll free: 1 855 STJOE81
Principal Display Panel
• ADULT ASPIRIN REGIMEN‡
LOW DOSE ASPIRIN
SAFETY COATED†
PAIN RELIEVER (NSAID)
81 mg
DOCTOR RECOMMENDED
Enteric Coated
Micro** Tablets
Dist. by: St. Josephs Health Products, LLC
Irvington, NY 10533
Find out more at stjosephaspirin.com
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Gluten Free
†Coating Helps Protect Against Stomach Upset
‡Talk to your doctor before starting an aspirin regimen. Aspirin is not right for everyone.
**Now in a new, smaller, easier to swallow "micro tablet"
Product Label
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 3 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 3 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 3 |
Products#
Every source-derived product name is available through these pages.
- Aspirin
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
- CELLULOSE, MICROCRYSTALLINE
- STARCH, CORN
- SILICON DIOXIDE
- SODIUM BICARBONATE
- SODIUM LAURYL SULFATE
- STEARIC ACID
- TALC
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76000-231 | 76000-231-15, 76000-231-36, 76000-231-12, 76000-231-20, 76000-231-30, 76000-231-65 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / BUCCAL | 42 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, DELAYED RELEASE / ORAL | 30 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EFFERVESCENT / ORAL | 1.5 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, EXTENDED RELEASE / ORAL | 160 mg | ||
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | 74G4R6TH13 | TABLET, EXTENDED RELEASE / ORAL | 24 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, DELAYED RELEASE / ORAL | 46 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FOR SUSPENSION / ORAL | 264 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | SOLUTION / RESPIRATORY (INHALATION) | 2 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 147 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 4 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | CAPSULE / ORAL | 320 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED / ORAL | 7 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | LOZENGE / ORAL | 100 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, EFFERVESCENT / ORAL | 57600 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE / ORAL | 6 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, COATED / ORAL | 10.6 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, FILM COATED / ORAL | 86 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg |
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 |
|---|---|---|---|---|---|---|
| 9ec79c37-7a13-40a7-ab8e-36eac9adfc32 | dcd96650-4dbe-43cf-abf4-ac08d160f1fc | 2025-01-08 | Warnings | dcd96650-4dbe-43cf-abf4-ac08d160f1fc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.