Label: ECOTRIN- aspirin tablet, coated
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NDC Code(s):
63029-311-01,
63029-311-14,
63029-311-32,
63029-311-45, view more63029-311-65, 63029-311-75
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 11, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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.
- hives
- Directions
- Other information
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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?
- PRINCIPAL DISPLAY PANEL
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ECOTRIN
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-311 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color orange Score no score Shape ROUND Size 8mm Flavor Imprint Code Ecotrin;Low Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-311-01 1 in 1 CARTON 06/01/2012 1 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:63029-311-14 1 in 1 CARTON 06/01/2012 2 14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:63029-311-65 1 in 1 CARTON 06/01/2012 3 365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:63029-311-75 1 in 1 CARTON 06/01/2012 4 175 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:63029-311-32 1 in 1 CARTON 06/01/2012 5 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC:63029-311-45 1 in 1 CARTON 06/01/2012 6 45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 06/01/2012 Labeler - Medtech Products Inc. (122715688)