Label: LOW DOSE ASPIRIN- aspirin tablet, delayed release
- NDC Code(s): 68210-5029-4
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 14, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each tablet) Aspirin 81 mg (NSAID)nonsterodial anti-inflammatory drug
- Purpose Pain reliever
- Uses
- Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes 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 olderHave had stomach ulcers or bleeding problemsTake a blood thinning (Anticogulant) or steroid drugTake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day using this product
- Do not Use if you are allergic to aspirin or any other pain reliever/fever reducerif you have ever had an allergic reaction to this product or any of its ingredients
- Ask a doctor before use if stomach bleeding warning applies to you you ahistory of stomach problems such as heart burnyou have blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic, you have asthama
- Ask a doctor or pharmacist before use if you are 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 an allergic reaction occurs. Seek medical help right away.You experience any of the following signs of stomach bleeding: feel faint, vomt blood, have bloody or black stools, have stomach pain that does not get better, pain get worse or lasts more than 10 days, fever gets worse or lasts more than 3 daysredness or swelling is present, new symptons occurringing in the ears or a loss of hearing occurs.
- If pregnant or breast-feeding ask ahealth professional before use. it is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it my cause problems in the unborn child or complications during delivery.
- Keep out of reach of children In case of overdose, get medical help or contact poison control center right away.
- Directions
- Other information
- Inactive ingredients
- Questions or Comments
- Principal Display
-
INGREDIENTS AND APPEARANCE
LOW DOSE ASPIRIN
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-5029 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 METHACRYLIC ACID (UNII: 1CS02G8656) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code 81 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-5029-4 1 in 1 CARTON 12/14/2023 1 40 in 1 BOTTLE; 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 12/14/2023 Labeler - Spirit Pharmaceuticals LLC (179621011)
