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 headache or other symptoms needing immediate relief.
Aspirin 81mg Enteric Coated
- Manufacturer
- Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED
- Effective date
- 2025-05-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:00:06
Label at a glance#
ProductAspirin 81mg Enteric Coated
Active ingredientASPIRIN
Label structure8 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: consult a doctor
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 81mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Purpose
Pain Reliever
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 headache 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
- 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 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
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
- 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
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 accidental 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:consult a doctor
Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients
Acrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow# 10, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Oxide of Iron.
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | DataBar Omni | (01)00377333031200 | GTIN-14: 00377333031200 GTIN-12: 377333031200 UPC-A: 377333031200 EAN-13: 0377333031200 GTIN storage (14 digits): 00377333031200 | label.jpg |
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 |
|---|---|---|---|---|---|---|
| 77333-031-20 | Aspirin 81mg Enteric Coated | 150 in 1 CARTON | TABLET, DELAYED RELEASE | 150 | 1 | |
| 77333-031-25 | Aspirin 81mg Enteric Coated | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 77333-031-20 | EA - Each | 77333-031 | 85eb169d-e2f9-45af-8243-e5450ed3cde8 | 1 | 2025-05-14 |
| 77333-031-25 | EA - Each | 77333-031 | f4575ebe-fdd0-4355-b91e-7fd0193f093a | 1 | 2025-05-14 |
Products#
Every source-derived product name is available through these pages.
- Aspirin 81mg Enteric Coated
- Aspirin
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10
- LACTOSE
- CELLULOSE, MICROCRYSTALLINE
- POLYSORBATE 80
- SODIUM HYDROXIDE
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
- FERRIC OXIDE YELLOW
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77333-031 | 77333-031-25, 77333-031-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIETHYL CITRATE | 8Z96QXD6UM | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
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 81mg Enteric Coated | ASPIRIN | Gendose Pharmaceuticals, LLC | 7342bbf4-ebb9-446d-83bb-6ddcb3a44fa7 | 2025-05-01 | Warnings | 77333-031-25 77333-031-20 77333-031 77333003120 77333003125 327b3759-64de-dc54-e063-6394a90ac525 7342bbf4-ebb9-446d-83bb-6ddcb3a44fa7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.