Label: ASPIRIN ENTERIC COATED- aspirin 81 mg tablet
- NDC Code(s): 69168-318-06, 69168-318-17, 69168-318-50
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 7, 2018
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- Official Label (Printer Friendly)
- 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, asthma (wheezing), shock.
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 are allergic to aspirinor 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 have asthma you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for anticoagulation (thinning the blood) diabetes gout arthritis
Stop use and ask a doctor if
an 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 new symptoms occur ringing in the ears or loss of hearing occurs
You may report side effects to 1-888-952-0050 - Keep Out of Reach of Children
- Directions
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Inactive Ingredients
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
May contain: starch
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
ASPIRIN ENTERIC COATED
aspirin 81 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-318 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) METHACRYLIC ACID (UNII: 1CS02G8656) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-318-50 1 in 1 CARTON 12/18/2014 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-318-06 1 in 1 CARTON 12/18/2014 2 120 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69168-318-17 300 in 1 BOTTLE; Type 0: Not a Combination Product 12/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 12/18/2014 Labeler - Allegiant Health (079501930)