Ecotrin Low Strength

Ecotrin Low Strength
SPL v2
SPL
SPL Set ID f950d4eb-39b9-4ef7-b5f3-0cf45d4d6bc0
Route
ORAL
Published
Effective Date 2012-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Edetic Acid Fd&c Yellow No. 6 Glyceryl Monostearate Hypromelloses Methylparaben Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Cellulose, Microcrystalline Polysorbate 80 Starch, Corn Propylparaben Stearic Acid Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: Ecotrin;Low Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-06-01

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Drug Facts

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

    • minor arthritis pain

    • toothache

    • menstrual pain

    • colds


  • or as recommended by a doctor
Section 42229-5

Drug Facts

Section 51945-4

The Aspirin Regimen That’s Smart For Your Heart

Ecotrin®

Safety Coated Aspirin (NSAID) Pain Reliever

#1 CARDIOLOGIST Recommended Aspirin

81 mg Low Strength

150 Tablets

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

  • shock

  • 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
Directions
  • adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.

  • do not take more than 48 tablets in 24 hours unless directed by a doctor

  • children under 12 years of age: ask a doctor
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) *81mg

*nonsteroidal anti-inflammatory drug

Other Information
  • Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.

  • store below 25ºC (77ºF)
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, EDTA, FD&C yellow#6, glyceryl monostearate, hypromellose, methacrylic acid copolymer, methylparaben, microcrystalline cellulose, polysorbate 80, propylparaben, starch, stearic acid, talc, titanium dioxide, triethyl citrate. Printed with edible ink.

Questions Or Comments?

call toll-free 1-866-255-5202 (English/Spanish) weekdays

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

  • 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 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.

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, or arthritis


Structured Label Content

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

    • minor arthritis pain

    • toothache

    • menstrual pain

    • colds


  • or as recommended by a doctor
Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

The Aspirin Regimen That’s Smart For Your Heart

Ecotrin®

Safety Coated Aspirin (NSAID) Pain Reliever

#1 CARDIOLOGIST Recommended Aspirin

81 mg Low Strength

150 Tablets

Purpose

Pain reliever

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

  • shock

  • 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
Directions
  • adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.

  • do not take more than 48 tablets in 24 hours unless directed by a doctor

  • children under 12 years of age: ask a doctor
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) *81mg

*nonsteroidal anti-inflammatory drug

Other Information (Other information)
  • Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.

  • store below 25ºC (77ºF)
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, EDTA, FD&C yellow#6, glyceryl monostearate, hypromellose, methacrylic acid copolymer, methylparaben, microcrystalline cellulose, polysorbate 80, propylparaben, starch, stearic acid, talc, titanium dioxide, triethyl citrate. Printed with edible ink.

Questions Or Comments? (Questions or comments?)

call toll-free 1-866-255-5202 (English/Spanish) weekdays

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

  • 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 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.

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, or arthritis


Advanced Ingredient Data


Raw Label Data

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