ecotrin regular

ecotrin regular
SPL v6
SPL
SPL Set ID 36cb530b-25b2-4f62-a25d-aa04360815a8
Route
oral
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (325 mg)
Inactive Ingredients
carnauba wax silicon dioxide edetic acid fd&c yellow no. 6 glyceryl monostearate hypromelloses methylparaben methacrylic acid and ethyl acrylate copolymer cellulose, microcrystalline polysorbate 80 starch, corn propylparaben stearic acid talc titanium dioxide triethyl citrate

Identifiers & Packaging

Pill Appearance
Imprint: Ecotrin;Reg Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2012-06-01

Purpose

Pain reliever

Description

Drug Facts


Medication Information

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

  • 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
Uses
  • temporarily relieves minor aches and pains due to:

    ▪ minor arthritis pain

    ▪ headache

    ▪ toothache

    ▪ menstrual pain

    ▪ muscle pain

    ▪ colds

  • or as recommended by a doctor
Purpose

Pain reliever

Directions
  • drink a full glass of water with each dose

  • a dults and children 12 years of age and over: take 1 to 2 tablets every 4 hours while symptoms last

  •  do not take more than 12 tablets in 24 hours unless directed by a doctor

  • children under 12 years of age: ask a doctor
Other Information
  • store at 25ºC (77ºF) excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number
Inactive Ingredients

black iron oxide, cellulose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Description

Drug Facts

Principal Display Panel

Ecotrin ®

Safety Coated Aspirin

(NSAID) Pain Reliever

325 mg Regular Strength



125 Tablets

Questions?

1-800-255-5202 Ecotrin.com

Section 42229-5

Drug Facts

Do Not Use

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Active Ingredient

(in each tablet)

Aspirin (NSAID*) 325mg

*nonsteroidal anti-inflammatory drug

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
Stop Use and Ask A Doctor If
  • 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

  • any new symptoms appear

  • 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 right away.

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • diabetes

  • gout

  • arthritis

Structured Label Content

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

  • 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
Uses
  • temporarily relieves minor aches and pains due to:

    ▪ minor arthritis pain

    ▪ headache

    ▪ toothache

    ▪ menstrual pain

    ▪ muscle pain

    ▪ colds

  • or as recommended by a doctor
Purpose

Pain reliever

Directions
  • drink a full glass of water with each dose

  • a dults and children 12 years of age and over: take 1 to 2 tablets every 4 hours while symptoms last

  •  do not take more than 12 tablets in 24 hours unless directed by a doctor

  • children under 12 years of age: ask a doctor
Other Information (Other information)
  • store at 25ºC (77ºF) excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

black iron oxide, cellulose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ecotrin ®

Safety Coated Aspirin

(NSAID) Pain Reliever

325 mg Regular Strength



125 Tablets

Questions?

1-800-255-5202 Ecotrin.com

Section 42229-5 (42229-5)

Drug Facts

Do Not Use (Do not use)

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Active Ingredient (Active ingredient)

(in each tablet)

Aspirin (NSAID*) 325mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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

  • any new symptoms appear

  • ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for

  • diabetes

  • gout

  • arthritis

Advanced Ingredient Data


Raw Label Data

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