Aspirin 325 mg
- Manufacturer
- WALGREENS | TIME CAP LABORATORIES, INC.
- Effective date
- 2022-07-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:54:51
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever
INDICATIONS & USAGE SECTION
Uses
• For the temporary relief of minor aches and pains due to:
o headache
o toothache
o muscle pain
o minor arthritis pain
o menstrual pain
o colds
• or as recommended by a doctor
WARNINGS SECTION
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 thinner (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
OTC - DO NOT USE SECTION
Do not use:
• If you have ever had an allergic reaction to any other pain reliever/fever reducer.
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis.
OTC - STOP USE SECTION
Stop use and ask a doctor if:
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
- an allergic reaction occurs
Seek medical help right away if:
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- drink a full glass of water with each dose.
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor.
- children under 12 years: ask a doctor.
OTHER SAFETY INFORMATION
Other information
•
each tablet contains: sodium 1 mg (VERY LOW SODIUM)
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
• use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD & C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-6453-53 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-6187-d83d-e063-dadaa90ab31f | 331R Walgreens 0363-6453 Aspirin 325 mg |
| 0363-6453-53 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6187-d83d-e063-dadaa90ab31f | 331R Walgreens 0363-6453 Aspirin 325 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-6453-53 | Aspirin 325 mg | 500 in 1 BOTTLE | TABLET | 500 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Aspirin 325 mg
- Aspirin
- D&C YELLOW NO. 10 ALUMINUM LAKE
- HYPROMELLOSE, UNSPECIFIED
- MINERAL OIL
- POLYSORBATE 80
- CROSCARMELLOSE SODIUM
- TITANIUM DIOXIDE
- MICROCRYSTALLINE CELLULOSE
- DIMETHICONE
- SODIUM LAURYL SULFATE
- METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- SODIUM HYDROXIDE
- TRIETHYL CITRATE
- STARCH, CORN
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-6453 | 0363-6453-53 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 325 mg | ASPIRIN | WALGREENS | d71a22e8-9e39-a672-e053-2a95a90a1403 | 2022-07-08 | Warnings | 0363-6453-53 0363-6453 00363645353 e3459ba6-a519-7ddc-e053-2a95a90a3394 d71a22e8-9e39-a672-e053-2a95a90a1403 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
