Indications and uses
temporarily relieves headache muscle pain toothache menstrual pain pain and fever of colds minor pain of arthritis
Aspirin
- Manufacturer
- Safetec of America, Inc.
- Effective date
- 2019-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:03:30
Label at a glance#
ProductAspirin
Active ingredientAspirin
Label structure11 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
Purposes
Pain reliever/fever reducer
Uses
temporarily relieves
- headache
- muscle pain
- toothache
- menstrual pain
- pain and fever of colds
- minor pain of arthritis
Warnings
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
SPL UNCLASSIFIED SECTION
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
OTC - DO NOT USE SECTION
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 asthma
OTC - ASK DOCTOR/PHARMACIST SECTION
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
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. 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
- store at room temperature 15°-30°C (59°-86°F)
Inactive ingredients
corn starch, povidone
Questions or comments?
Call toll free: 1-800-456-7077
Principal Display Panel - 325 mg Pouch Label
Safetec
of America, Inc.
DO NOT USE IF POUCH IS TORN OR DAMAGED
Manufactured for Safetec of America, Inc.
Buffalo NY 14215
Aspirin Pain Reliever/Fever Reducer
ORIGINAL STRENGTH
2 Tablets
Principal Display Panel – 50 Count Carton Label
Safetec®
of America, Inc.
*Compare to the active ingredient in
Bayer Genuine Aspirin®
NDC 61010-4407-1
ORIGINAL STRENGTH
Aspirin
Aspirin 325 mg Pain Reliever/Fever Reducer
PUSH TO OPEN
Dispense
through opening
- Relieves minor aches and pains
- Fever reducer
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
50 Pouches 2 Tablets per Pouch
Principal Display Panel – 100 Count Carton Label
Safetec®
of America, Inc.
*Compare to the active ingredient in
Bayer Genuine Aspirin®
NDC 61010-4407-2
ORIGINAL STRENGTH
Aspirin
Aspirin 325 mg – Pain Reliever/Fever Reducer
- Relieves minor aches and pains
- Fever reducer
PUSH TO OPEN
Dispense
through opening
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
100 Pouches 2 Tablets per Pouch
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-4407-0 | Aspirin | 2 in 1 POUCH | TABLET | 2 | 2 | |
| 61010-4407-1 | Aspirin | 50 in 1 BOX | TABLET | 50 | 2 | |
| 61010-4407-2 | Aspirin | 100 in 1 BOX | TABLET | 100 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-4407 | ASPIRIN TABLET [SAFETEC OF AMERICA, INC.] | 2 | Legacy NDC, 3 package rows | 20200129_563820a8-c90c-45f2-8af4-a457bb094546.zip |
Products#
Every source-derived product name is available through these pages.
- Aspirin
- starch, corn
- povidone
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61010-4407 | 61010-4407-0, 61010-4407-1, 61010-4407-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Aspirin | R16CO5Y76E | ACTIB |
| starch, corn | O8232NY3SJ | IACT |
| povidone | FZ989GH94E | IACT |
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 |
|---|---|---|---|---|---|---|
| adc3c9bf-3c0e-4502-abd9-2e93433a2f67 | 563820a8-c90c-45f2-8af4-a457bb094546 | 2019-12-30 | Warnings | adc3c9bf-3c0e-4502-abd9-2e93433a2f67 563820a8-c90c-45f2-8af4-a457bb094546 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.