ECOTRIN- aspirin tablet, coated
Medtech Products Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
(in each tablet)
Aspirin (NSAID) *81mg
*nonsteroidal anti-inflammatory drug
- for the temporary relief of minor aches and pains due to:
- minor arthritis pain
- menstrual pain
- the common cold
- or as recommended by a doctor
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:
- facial swelling
- 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
- 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
if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
- 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
taking a prescription drug for ▪ diabetes ▪ gout ▪arthritis
- 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.
- pain gets worse or lasts more than 10 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.
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- 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
- Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.
- store at 25°C (77°F); exclusions permitted between 15°C-30°C (59°F-86°F)
- avoid excessive heat and humidity
- see end flap for expiration date and lot number
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
Safety Coated Aspirin (NSAID) Pain Reliever
81 mg Low Strength
32 Enteric Coated TabletsPRINCIPAL DISPLAY PANEL Ecotrin® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 32 Enteric Coated Tablets
|ECOTRIN aspirin tablet, coated|
|Labeler — Medtech Products Inc. (122715688)|
Revised: 04/2020 Medtech Products Inc.
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.