Enteric Coated Aspirin
- Manufacturer
- CARDINAL HEALTH | TIME CAP LABORATORIES, INC
- Effective date
- 2019-12-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:56:02
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
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 (1-800 222-1222) right away |
DOSAGE & ADMINISTRATION SECTION
Directions
|
INACTIVE INGREDIENT SECTION
| corn starch, croscarmellose sodium,D-C yellow #10 aluminum lake, FD-C yellow#6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate |
INDICATIONS & USAGE SECTION
Use for the temporary relief of minor aches and pains due to: headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor |
OTC - PURPOSE SECTION
| Pain Reliever |
WARNINGS SECTION
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, asthmaaa9wheezing) 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 - ACTIVE INGREDIENT SECTION
| In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug |
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0237-1 | EA - Each | 70000-0237 | 144cae13-8c1b-4a6f-aed8-b71bb3fda0c6 | 1 | 2018-12-13 |
| 70000-0237-2 | EA - Each | 70000-0237 | b6a92940-9fcc-44ff-9351-6ad1af6a272a | 1 | 2018-12-13 |
Products#
Every source-derived product name is available through these pages.
- Enteric Coated Aspirin Regular Strength
- Aspirin
- MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
- CELLULOSE, MICROCRYSTALLINE
- MINERAL OIL
- POLYSORBATE 80
- DIMETHICONE
- SILICON DIOXIDE
- SODIUM HYDROXIDE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
- HYPROMELLOSES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0237 | 70000-0237-1, 70000-0237-2 |
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 |
|---|---|---|---|---|---|---|
| 98cfdbf4-7807-ac2b-e053-2995a90adb96 | 4f31fc1d-2a1f-4fd5-84e3-17858765d97c | 2019-12-03 | Warnings | 98cfdbf4-7807-ac2b-e053-2995a90adb96 4f31fc1d-2a1f-4fd5-84e3-17858765d97c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

