Label: ECOTRIN REGULAR STRENGTH- aspirin tablet, coated
- NDC Code(s): 63029-302-01, 63029-302-02
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 11, 2019
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
- 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
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 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
- 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.
- hives
- Directions
- Other information
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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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ECOTRIN REGULAR STRENGTH
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-302 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETIC ACID (UNII: 9G34HU7RV0) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code Ecotrin;Reg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-302-01 1 in 1 CARTON 06/01/2012 1 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:63029-302-02 1 in 1 BOX 06/01/2012 2 125 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 FINAL part343 06/01/2012 Labeler - Medtech Products Inc. (122715688)
