Indications and uses
Temporarily relieves minor aches and pains due to • headache • muscle pain • toothache • menstrual pain • colds • minor pain of arthritis Temporarily reduces fever
Bayer Aspirin
- Manufacturer
- Navajo Manufacturing Company Inc.
- Effective date
- 2019-11-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:03:09
Label at a glance#
ProductBayer Aspirin
Active ingredientASPIRIN
Label structure8 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 • children under 12 years: consult a doctor
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 minor aches and pains due to
• headache • muscle pain • toothache • menstrual pain • colds • minor pain of arthritis
Temporarily reduces fever
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 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
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
• 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 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
• children under 12 years: consult a doctor
Other information
• do not use if pouch is open or torn
• save carton for full directions and warnings
• store at room temperature
Inactive ingredients
corn starch, hypromellose, powdered cellulose, triacetin
Questions or comments?
1-800-331-4536 (Mon – Fri 9AM – 5PM EST)
Package Labeling:
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67751-172-01 | 2023-03-15 | C162847 | 48780-1 | f386c649-99a1-0266-e053-dadaa90a7c1a | Bayer Aspirin |
| 67751-172-02 | 2023-03-15 | C162847 | 48780-1 | f386c649-99a1-0266-e053-dadaa90a7c1a | Bayer Aspirin |
| 67751-172-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-99a1-0266-e053-dadaa90a7c1a | Bayer Aspirin |
| 67751-172-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-99a1-0266-e053-dadaa90a7c1a | Bayer Aspirin |
Products#
Every source-derived product name is available through these pages.
- Bayer Aspirin
- ASPIRIN
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
- POWDERED CELLULOSE
- TRIACETIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67751-172 | 67751-172-01, 67751-172-02 |
| 0280-2605 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POWDERED CELLULOSE | SMD1X3XO9M | IACT |
| TRIACETIN | XHX3C3X673 | 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 |
|---|---|---|---|---|---|---|
| f5dbd2cf-dcdb-6d21-e053-2a95a90a13bb | 184248c7-7505-43db-a908-2c34791ef272 | 2023-03-01 | Warnings | 184248c7-7505-43db-a908-2c34791ef272 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.