Indications and uses
◾ temporarily relieves ◾ muscle pain ◾ menstrual pain ◾ minor pain of arthritis
Aspirin 81 mg
- Manufacturer
- VITANE PHARMACEUTICALS, INC | VITANE PHARMACEUTICALS, INC.
- Effective date
- 2021-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:19:53
Label at a glance#
ProductAspirin 81 mg Low Dose
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 at 25ºC excursions permitted between 15º-30ºC ◾ Use by expiration date on package
Contacts and useful links#
Websitewww.vitanepharma.com
www.vitanepharma.com
www.vitanepharma.comLabel contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
◾ temporarily relieves
◾ muscle pain
◾ menstrual pain
◾ minor pain of arthritis
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 ulcer 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
◾ 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
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
◾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 more than 10 days
◾ redness or swelling is present
◾ fever lasts more than 3 days
◾ new symptoms occur
◾ 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 (1-800-222-1222) 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.
Other information:
◾ Store at 25ºC excursions permitted between 15º-30ºC
◾ Use by expiration date on package
Other Ingredients:
Microcrystalline Cellulose, Croscarmellose sodium, Methacrylic acid copolymer, Titanium dioxide, Talcum, Stearic acid, Colloidal silicon dioxide, Triethyl citrate, D&C Yellow #10, FD&C Yellow #6.
Questions or comments?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 60577-005-01
Vitane's Aspirin 81 mg
Pain Reliever (NSAID)*
Low Dose Safety Coated | Aspirin Regimen**
60 Enteric Coated Tablets
**Talk to your doctor or other healthcare provider before using this product for your heart.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
MADE IN USA
Manufactured By:
Vitane Pharmaceuticals, Inc.
125 Wells Avenue
Congers, NY 10920 USA
www.vitanepharma
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 60577-005-01 | 2023-09-16 | C162847 | 48780-1 | f386c64a-1f76-0266-e053-dadaa90a7c1a | Aspirin 81 mg -Low Dose Safety Coated |
| 60577-005-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1f76-0266-e053-dadaa90a7c1a | Aspirin 81 mg -Low Dose Safety Coated |
Products#
Every source-derived product name is available through these pages.
- Aspirin 81 mg Low Dose
- Aspirin
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- METHACRYLIC ACID
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
- SILICON DIOXIDE
- CELLULOSE, MICROCRYSTALLINE
- CROSCARMELLOSE SODIUM
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60577-005 | 60577-005-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| METHACRYLIC ACID | 1CS02G8656 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIETHYL CITRATE | 8Z96QXD6UM | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| e062be99-7796-47ba-a846-295a74797343 | 413789cc-60ce-45f0-80c5-cb3de3e96a62 | 2023-09-16 | Warnings | 413789cc-60ce-45f0-80c5-cb3de3e96a62 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.