Indications and uses
for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
Aspirin
- Manufacturer
- ATLANTIC BIOLOGICALS CORP.
- Effective date
- 2025-06-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:05:53
Label at a glance#
ProductAspirin Low Dose
Active ingredientASPIRIN
Label structure10 sections
Dosage and administration
drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Description
NDC 17856-3086-01
Talk to your doctor or other healthcare provider before using this product for your heart.
Low Dose
Aspirin 81 mg
Safety Coated
Pain Reliever (NSAID)
Aspirin Regimen
100 Enteric Coated Tablets
Uses
for the temporary relief of minor aches and pains or as recommended by your doctor.
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
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
- shock
- asthma (wheezing)
Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- take more or for a longer time than directed
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- have 3 or more alcoholic drinks every day while using this product
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
- you have asthma
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
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:
- vomit blood
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- vomit blood
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
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 (1-800-222-1222) right away.
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate
Questions or comments?
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-3086-1 | 2025-04-18 | C162847 | 48780-1 | f386c64a-26ff-0266-e053-dadaa90a7c1a | Aspirin 81mg Low-dose |
| 17856-3086-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-26ff-0266-e053-dadaa90a7c1a | Aspirin 81mg Low-dose |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-3086-1 | AspirinLow Dose | 1 in 1 BOX, UNIT-DOSE | TABLET, DELAYED RELEASE | 1 | 3 | |
| 17856-3086-1 | AspirinLow Dose | 1 in 1 POUCH | TABLET, DELAYED RELEASE | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-3086-1 | EA - Each | 17856-3086 | 4226316e-1064-4099-b6f4-af63f773d033 | 1 | 2022-05-04 |
| 0536-1234-41 | EA - Each | 0536-1234 | 27f06810-6187-43ff-bc6b-ba3b6bc92876 | 1 | 2019-09-05 |
Products#
Every source-derived product name is available through these pages.
- Aspirin Low Dose
- Aspirin
- STARCH, CORN
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- METHACRYLIC ACID
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SHELLAC
- SILICON DIOXIDE
- SODIUM BICARBONATE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
- DIMETHICONE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 17856-3086 | 17856-3086-1 |
| 0536-1234 |
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 Low Dose | ASPIRIN | Rugby Laboratories | 63fcd93a-b1db-44ba-8f2b-055a7deb205d | 2026-06-04 | Warnings | 0536-1234 |
| Aspirin Low Dose | ASPIRIN | ATLANTIC BIOLOGICALS CORP. | 024c5054-959f-4ea5-a71f-c0e16cc4b90c | 2025-06-24 | Warnings | 17856-3086-1 17856-3086 17856308601 385229c2-9b6a-56ca-e063-6394a90aa5b7 024c5054-959f-4ea5-a71f-c0e16cc4b90c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.