Label: ASPIRIN 81 MG ENTERIC COATED- aspirin tablet
- NDC Code(s): 10135-173-62
- Packager: Marlex Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 18, 2019
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SPL UNCLASSIFIED SECTION
ASPIRIN 81 MG ENTERIC COATED- aspirin tablet Reliable 1 Laboratories LLC
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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Aspirin USP 81mg Enteric Coated Tablet
Drug Facts
- Active ingredients (in each tablet)
- 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 symptons could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which any include:
- Hives
- facial swelling shock
- asthma (wheezing)
Somach bleeding warning: This product contains 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 steriod 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
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
- you have not been dirinking fluids
- you have lost a lot of fluid due to vomiting or diarrhea
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis taking any other drug
- under a doctor's care for any serious condition
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
- have bloody or black stools vomit blood
- 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 a loss of hearing occurs
These could be sings of a serious condition.
- Hives
- Directions
- Other information
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Inactive ingredients
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN 81 MG ENTERIC COATED
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10135-173 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) IRON (UNII: E1UOL152H7) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color YELLOW Score no score Shape ROUND Size 5mm Flavor Imprint Code Heart Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10135-173-62 120 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 08/01/2018 Labeler - Marlex Pharmaceuticals Inc (782540215)
