Storage and handling
Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Active ingredient (in each tablet) Purpose
Aspirin 325 mg (NSAID*).............................Pain reliever
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
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 or 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 inclue:
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
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
Other information
Inactive ingredients
corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
Questions?
To Report Adverse Drug Event Call:
(800) 616-2471
| 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 |
|---|---|---|---|---|---|
| 67046-170-07 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9cb-a426-e053-dadaa90af4c2 | DRUG FACTS 170 |
| 67046-170-14 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9cb-a426-e053-dadaa90af4c2 | DRUG FACTS 170 |
| 67046-170-15 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9cb-a426-e053-dadaa90af4c2 | DRUG FACTS 170 |
| 67046-170-21 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9cb-a426-e053-dadaa90af4c2 | DRUG FACTS 170 |
| 67046-170-28 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9cb-a426-e053-dadaa90af4c2 | DRUG FACTS 170 |
| 67046-170-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9cb-a426-e053-dadaa90af4c2 | DRUG FACTS 170 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-170-07 | Regular Strength Aspirin EC | 7 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 7 | 1 | |
| 67046-170-14 | Regular Strength Aspirin EC | 14 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 14 | 1 | |
| 67046-170-15 | Regular Strength Aspirin EC | 15 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 15 | 1 | |
| 67046-170-21 | Regular Strength Aspirin EC | 21 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 21 | 1 | |
| 67046-170-28 | Regular Strength Aspirin EC | 28 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 28 | 1 | |
| 67046-170-30 | Regular Strength Aspirin EC | 30 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 30 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-2013-60 | EA - Each | 0904-2013 | c84ce7b9-9f6f-4975-8189-fae1baf2231b | 1 | 2012-07-24 |
| 0904-2013-72 | EA - Each | 0904-2013 | b1d173aa-914a-48c8-9050-e6fceae291bf | 1 | 2012-07-24 |
| 0904-2013-80 | EA - Each | 0904-2013 | 553a24cd-9975-414f-8b60-671e643bf568 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67046-170 | 67046-170-07, 67046-170-14, 67046-170-15, 67046-170-21, 67046-170-28, 67046-170-30 |
| 0904-2013 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 598b819f-98ce-8ecf-e053-2a91aa0aeadc | 598b819f-98cd-8ecf-e053-2a91aa0aeadc | 2017-09-19 | Warnings | 598b819f-98ce-8ecf-e053-2a91aa0aeadc 598b819f-98cd-8ecf-e053-2a91aa0aeadc |
Adverse event summaries are temporarily unavailable. Other product information remains available.