OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT IN EACH TABLET- ASPIRIN 325 MG
ACTIVE INGREDIENT IN EACH TABLET- ASPIRIN 325 MG
PAIN RELIEVER/FEVER REDUCER
Uses:
temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis•
muscle pain • pain and fever of colds • toothache • temporarily reduces fever
Uses:
temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis
•
muscle pain • pain and fever of colds • toothache • 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 nonsteroidal anti-inflammatory drugs (NSAIDs),
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 prescription or nonprescription containing an NSAID [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 are taking a diuretic • you have a sodium-restricted diet
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:
• you feel faint, vomit blood, or have bloody
or black stools
• redness or swelling is present • pain gets worse or lasts more than 10 days • fever lasts
more than 3 days
• new symptoms occur • ringing in the ears or a loss of hearing occurs
If pregnant or breast-feeding baby,
ask a health professional
before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN
DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS
SPECIFIC-ALLY 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. Prompt medical attention is critical for
adults as well as for children even if you do not notice any signs or symptoms.
Directions:
•
Drink a full glass of water with each dose
Adults and children 12 years OR OLDER :TAKE 2 TABLETS EVERY 4-6 HOURS AS needed, do not exceed 12 tablets in
24 hours, or as directed by a doctor.
Children under 12 YEARSOF AGE
• consult a doctor
Inactive Ingredients:
microcrystalline cellulose,
povidone, pregelatinized starch
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67060-232-68 | 2023-01-30 | C162847 | 48780-1 | f386c649-cbe0-0266-e053-dadaa90a7c1a | 7369cf7e-b1b8-4faf-982c-454e2ae6cbfa |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67060-232-02 | ADVANCED ASPIRIN | 2 in 1 PACKET | TABLET | 2 | 1 | |
| 67060-232-68 | ADVANCED ASPIRIN | 100 in 1 CARTON | TABLET | 100 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67060-232 | 67060-232-02, 67060-232-68 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
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 |
|---|---|---|---|---|---|---|
| 627cbe02-0c2e-41ef-a26f-6fb7dce0c13f | 7369cf7e-b1b8-4faf-982c-454e2ae6cbfa | 2015-04-07 | Warnings | 627cbe02-0c2e-41ef-a26f-6fb7dce0c13f 7369cf7e-b1b8-4faf-982c-454e2ae6cbfa |
Adverse event summaries are temporarily unavailable. Other product information remains available.