ECOTRIN
-
aspirin tablet, coated
GlaxoSmithKline Consumer Healthcare LP
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.
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Active ingredient (in each tablet) (Low Strength)
Aspirin (NSAID)* 81mg
*nonsteroidal anti-inflammatory drug
Active ingredient (in each tablet) (Regular Strength)
Aspirin (NSAID)* 325mg
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- headache
- menstrual pain
- minor arthritis pain
- muscle pain
- toothache
- colds
- or as recommended by a 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
- 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
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 warnings 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
Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis
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.
Directions (Low Strength)
- adults and children 12 years of age or 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
Directions (Regular Strength)
- adults and children 12 years of age or over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
- 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
- Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.
- store below 25°C (77°F)
Inactive ingredients (Low Strength)
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 black ink.
Inactive ingredients (Regular Strength)
carnauba wax, colloidal silicon dioxide, EDTA, FD&C yellow#6, glyceryl monostearate, hypromellose, methacrylic acid copolymer, methylparaben, microcrystalline cellulose, polysorbate 80, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid, talc, titanium dioxide, triethyl citrate. Printed with edible ink.
Questions or comments?
call toll-free 1-800-245-1040 (English/Spanish) weekdays
ECOTRIN is a registered trademark of the GlaxoSmithKline group of companies.
GlaxoSmithKline Consumer Healthcare, L.P.
Moon Township, PA 15108, Made in Thailand
www.ecotrin.com
Principal Display Panel (Low Strength)
NDC 0135-0117-88
Ecotrin®
Safety Coated Aspirin (NSAID)Pain Reliever
The Aspirin Regimen That's Smart For Your Heart
#1 CARDIOLOGIST Recommended Aspirin
81mg Low Strength
365 Tablets
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.
VALUE SIZE!
©2011 GlaxoSmithKline
100183XB
Principal Display Panel (Regular Strength)
NDC 0135-0014-30
Ecotrin®
Safety Coated Aspirin (NSAID)Pain Reliever
The Aspirin Regimen That's Smart For Your Heart
#1 CARDIOLOGIST Recommended Aspirin
325mg Regular Strength
300 Tablets
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.
VALUE SIZE!
©2011 GlaxoSmithKline
100198XB
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aspirin tablet, coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part343 | 11/12/2010 | |
| ECOTRIN
aspirin tablet, coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part343 | 11/12/2010 | |
| Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212) |
Revised: 09/2011 GlaxoSmithKline Consumer Healthcare LP