Indications and uses
temporarily relieves: pain and fever of colds headache muscle pain minor pain of arthritis toothache menstrual pain
Aspirin
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2021-02-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:52:00
Label at a glance#
ProductAspirin NSAID
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 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor
Storage and handling
use by expiration date on package store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves:
- pain and fever of colds
- headache
- muscle pain
- minor pain of arthritis
- toothache
- menstrual pain
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:
- facial swelling
- shock
- hives
- 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
- 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
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
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
- 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:
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- vomit blood
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
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 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
Other information
- use by expiration date on package
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive ingredient
corn starch
Questions or comments?
1-800-540-3765
Principal Display Panel
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4667-3 | 2020-09-16 | C162847 | 48780-1 | 9d75b9d1-1bc9-f424-e053-dadaa90a57ce | Geri Care 44-249 |
| 68071-4667-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1bc9-f424-e053-dadaa90a57ce | Geri Care 44-249 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-901-01 | EA - Each | 57896-901 | 04fcb1c0-536e-42ab-945c-7e0952d99327 | 1 | 2014-11-05 |
| 57896-901-10 | EA - Each | 57896-901 | dd688c70-e3dc-41ed-b240-685e4ace336b | 1 | 2014-11-05 |
Products#
Every source-derived product name is available through these pages.
- Aspirin NSAID
- Aspirin
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-4667 | 68071-4667-3 |
| 57896-901 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | 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 |
|---|---|---|---|---|---|---|
| Aspirin | ASPIRIN | Geri-Care Pharmaceuticals, Corp | 58941782-362d-4436-b365-e909bdbd29a2 | 2026-07-15 | Warnings | 57896-901 |
| 1ab87e4e-828d-75dd-e063-6294a90a8121 | 7d00bddc-c10b-d6ee-e053-2991aa0a9854 | 2024-06-12 | Warnings | 7d00bddc-c10b-d6ee-e053-2991aa0a9854 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.