Indications and uses
temporarily relieves minor aches and pains due to: minor pain from arthritis headache menstrual pain pain and feverr of colds toothache muscle pain
Aspirin Enteric Coated, Regular Strength - Gendose Pharmaceuticals, LLC
- Manufacturer
- Gendose Pharmaceuticals, LLC
- Effective date
- 2026-05-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:57:26
Label at a glance#
ProductAspirin Enteric Coated, Regular Strength
Active ingredientASPIRIN
Label structure9 sections
Dosage and administration
do not take more than directed 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 to exceed 12 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)
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pains due to:
- minor pain from arthritis
- headache
- menstrual pain
- pain and feverr of colds
- toothache
- muscle pain
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
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 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not take more than directed
- 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 to exceed 12 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)
Inactive ingredients
black iron oxide, cellulose, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate
Questions or comments?
Call 1-888-676-7161
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)00377333035208 | GTIN-14: 00377333035208 GTIN-12: 377333035208 UPC-A: 377333035208 EAN-13: 0377333035208 GTIN storage (14 digits): 00377333035208 | label.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77333-035-20 | AspirinEnteric Coated, Regular Strength | 150 in 1 BOX | TABLET, DELAYED RELEASE | 150 | 1 | |
| 77333-035-25 | AspirinEnteric Coated, Regular Strength | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Aspirin Enteric Coated, Regular Strength
- Aspirin
- FERROSOFERRIC OXIDE
- POWDERED CELLULOSE
- SILICON DIOXIDE
- STARCH, CORN
- D&C YELLOW NO. 10 ALUMINUM LAKE
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- HYPROMELLOSE, UNSPECIFIED
- METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- SHELLAC
- DIMETHICONE
- WATER
- SODIUM BICARBONATE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77333-035 | 77333-035-25, 77333-035-20 |
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 Enteric Coated, Regular Strength | ASPIRIN | Gendose Pharmaceuticals, LLC | 10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa | 2026-05-15 | Warnings | 77333-035-25 77333-035-20 77333-035 77333003520 77333003525 50fc4202-32ea-7849-e063-6394a90a5a73 10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.