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.
ENTERIC COATED ASPIRIN
- Manufacturer
- Magno-Humphries, Inc.
- Effective date
- 2023-10-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:58:15
Label at a glance#
ProductENTERIC COATED ASPIRIN
Active ingredientASPIRIN
Label structure9 sections
Dosage and administration
• drink a full glass of water with each dose • take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in 24 hours unless directed by a doctor • consult a doctor adults and children 12 years and over: children under 12 years:
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 headaches or other symptoms needing immediate relief.
Warnings
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. 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
Reye’s syndrome:
Allergy alert:
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 or 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 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 • take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in 24 hours unless directed by a doctor • consult a doctor adults and children 12 years and over: children under 12 years:
Other information
• store at 25°C (77°F); excursions permitted between 15°- 30°C (59°-86°F)
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?
call toll-free 1-800-935-6737
Package Labeling: 54257-274-25
Package Labeling: 54257-274-06
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54257-274-06 | ENTERIC COATED ASPIRIN | 1000 in 1 BOTTLE | TABLET | 1000 | 4 | |
| 54257-274-25 | ENTERIC COATED ASPIRIN | 120 in 1 BOTTLE | TABLET | 120 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54257-274-06 | EA - Each | 54257-274 | 796502b2-710b-4d50-aa1e-69249faa16ee | 1 | 2022-09-12 |
| 54257-274-25 | EA - Each | 54257-274 | f7c178fb-4cf0-4568-ae04-a9f735e7f290 | 1 | 2024-04-05 |
Products#
Every source-derived product name is available through these pages.
- ENTERIC COATED ASPIRIN
- ASPIRIN
- STARCH, CORN
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- METHACRYLIC ACID
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SILICON DIOXIDE
- SODIUM BICARBONATE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54257-274 | 54257-274-25, 54257-274-06 |
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 |
|---|---|---|---|---|---|---|
| ENTERIC COATED ASPIRIN | ASPIRIN | Magno-Humphries, Inc. | a7c02378-4213-4e57-aca2-2437ad02f786 | 2023-10-27 | Warnings | 54257-274-25 54257-274-06 54257-274 54257027425 54257027406 08bf7b4e-4f73-7538-e063-6394a90a6627 a7c02378-4213-4e57-aca2-2437ad02f786 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.