Indications and uses
temporarily relieves minor aches and pain due to: headache minor arthritis pain toothache muscle pain menstrual pain colds or as recommended by your doctor
Ecotrin
- Manufacturer
- Medtech Products Inc.
- Effective date
- 2025-01-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:52:39
Label at a glance#
ProductEcotrin
Active ingredientASPIRIN
Label structure12 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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
(in each tablet)
Aspirin (NSAID) *81mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pain due to:
- headache
- minor arthritis pain
- toothache
- muscle pain
- menstrual pain
- colds
- headache
- or as recommended by your doctor
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
- are age 60 or older
- take more or for a longer time than directed
- 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
Do not use
if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
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
- 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
- feel faint
- an allergic reaction occurs. Seek medical help right away.
- any new symptoms appear
- ringing in the ears or a loss of hearing occurs.
- pain gets worse or lasts more than 10 days
- redness or swelling is present.
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
- 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 doctorchildren under 12 years: do not use unless directed by a doctor
Other information
- store at 25°C (77°F); exclusions permitted between 15°C-30°C (59°F-86°F)
- see end flap for expiration date and lot number
- avoid excessive heat and humidity
Inactive ingredients
black iron oxide, colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Questions or comments?
1-866-255-5202 Ecotrin.com
PRINCIPAL DISPLAY PANEL
Ecotrin®
Safety Coated Aspirin (NSAID) Pain Reliever
81 mg Low Strength
45 Tablets
PRINCIPAL DISPLAY PANEL
Ecotrin®
Safety Coated Aspirin (NSAID) Pain Reliever
81 mg Low Strength
150 Tablets
PRINCIPAL DISPLAY PANEL
Ecotrin®
Safety Coated Aspirin (NSAID) Pain Reliever
81 mg Low Strength
365 Tablets
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | PSN | 5 |
| 1189781 | Ecotrin 81 MG Delayed Release Oral Tablet | PSN | 5 |
| 1189781 | aspirin 81 MG Delayed Release Oral Tablet [Ecotrin] | SBD | 5 |
| 308416 | aspirin 81 MG Delayed Release Oral Tablet | SCD | 5 |
| 308416 | ASA 81 MG Delayed Release Oral Tablet | SY | 5 |
| 1189781 | ASA 81 MG Delayed Release Oral Tablet [Ecotrin] | SY | 5 |
| 308416 | aspirin 81 MG Enteric Coated Oral Tablet | SY | 5 |
| 1189781 | Ecotrin 81 MG Delayed Release Oral Tablet | SY | 5 |
| 1189781 | Ecotrin Low Strength 81 MG Delayed Release Oral Tablet | SY | 5 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63029-311-01 | Ecotrin | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 63029-311-01 | Ecotrin | 150 in 1 BOTTLE, PLASTIC | TABLET, COATED | 150 | 5 | |
| 63029-311-14 | Ecotrin | 14 in 1 BOTTLE, PLASTIC | TABLET, COATED | 14 | 5 | |
| 63029-311-14 | Ecotrin | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 63029-311-32 | Ecotrin | 32 in 1 BOTTLE, PLASTIC | TABLET, COATED | 32 | 5 | |
| 63029-311-32 | Ecotrin | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 63029-311-45 | Ecotrin | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 63029-311-45 | Ecotrin | 45 in 1 BOTTLE, PLASTIC | TABLET, COATED | 45 | 5 | |
| 63029-311-65 | Ecotrin | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 63029-311-65 | Ecotrin | 365 in 1 BOTTLE, PLASTIC | TABLET, COATED | 365 | 5 | |
| 63029-311-75 | Ecotrin | 175 in 1 BOTTLE, PLASTIC | TABLET, COATED | 175 | 5 | |
| 63029-311-75 | Ecotrin | 1 in 1 CARTON | TABLET, COATED | 1 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63029-311-32 | EA - Each | 63029-311 | 5af8a566-1d61-48e0-a6f6-02c2f0b02dde | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Polyvinyl Acetate Phthalate | INACTIVE INGREDIENT | 58QVG85GW3 | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | 1 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 1 |
Products#
Every source-derived product name is available through these pages.
- Ecotrin
- Aspirin
- FERROSOFERRIC OXIDE
- SILICON DIOXIDE
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- HYPROMELLOSES
- CELLULOSE, MICROCRYSTALLINE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- Polyvinyl Acetate Phthalate
- PROPYLENE GLYCOL
- SODIUM ALGINATE
- SODIUM BICARBONATE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63029-311 | 63029-311-01, 63029-311-14, 63029-311-65, 63029-311-75, 63029-311-32, 63029-311-45 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | TABLET / ORAL | 480 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| Polyvinyl Acetate Phthalate | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | CAPSULE, EXTENDED RELEASE / ORAL | 32 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | CAPSULE / ORAL | 160 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, DELAYED RELEASE / ORAL | 70 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| Polyvinyl Acetate Phthalate | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | TABLET, EXTENDED RELEASE / ORAL | 110 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, FILM COATED / ORAL | 3 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | LOZENGE / ORAL | 1274 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 7 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | TABLET / ORAL | 480 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, DELAYED RELEASE / ORAL | 120 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 7 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | TABLET, EXTENDED RELEASE / ORAL | 627 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET / ORAL | 52 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| Polyvinyl Acetate Phthalate | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | CAPSULE / ORAL | 48 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | LOZENGE / ORAL | 1274 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 100 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| Polyvinyl Acetate Phthalate | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | TABLET, DELAYED RELEASE / ORAL | NA | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 147 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| Polyvinyl Acetate Phthalate | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | TABLET, EXTENDED RELEASE / ORAL | 110 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, EXTENDED RELEASE / ORAL | 160 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | LOZENGE / ORAL | 1274 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, DELAYED RELEASE / ORAL | 70 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED / ORAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, EXTENDED RELEASE / ORAL | 160 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | GRANULE, FOR SUSPENSION / ORAL | 64 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | TROCHE / ORAL | 525 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | TROCHE / ORAL | 525 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, DELAYED RELEASE / ORAL | 120 mg | ||
| Polyvinyl Acetate Phthalate | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | TABLET, EXTENDED RELEASE / ORAL | 110 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 100 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | TABLET, EXTENDED RELEASE / ORAL | 627 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| Polyvinyl Acetate Phthalate | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | CAPSULE / ORAL | 48 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | GRANULE, FOR SUSPENSION / ORAL | 64 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | TABLET / ORAL | 480 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 147 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED / ORAL | 7 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, CHEWABLE / ORAL | 34 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 100 mg |
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 |
|---|---|---|---|---|---|---|
| Ecotrin | ASPIRIN | Medtech Products Inc. | 222d187b-aae6-410b-baeb-b2bd42f5c676 | 2025-01-16 | Warnings | 63029-311-14 63029-311-01 63029-311-65 63029-311-32 63029-311-75 63029-311-45 63029-311 63029031101 63029031114 63029031145 63029031175 63029031132 63029031165 1a591668-8b01-438a-8fa1-0f01ede86790 222d187b-aae6-410b-baeb-b2bd42f5c676 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.