Label: ASSURED ASPIRIN- aspirin tablet, delayed release
- NDC Code(s): 68210-0015-6
- Packager: SPIRIT PHARMACEUTICALS LLC
- 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.
Updated March 15, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever or other symptoms needing immediate relief.
- ask your doctor about other uses for Aspirin 81 mg
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.
Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
Stomach bleeding warning
This product contains an NSAID, which may cause 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
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:
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical 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 a loss of hearing occurs
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may 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 a Poison Control Center right away.
- drink a full glass of water with each dose
- adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor
- Other information
- each tablet contains: sodium 0.36 mg
- save carton for full directions and warnings
- store at room temperature
- Inactive ingredients
acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of ironClose
- Questions or comments?
- SPL UNCLASSIFIED SECTION
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
- PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton
COMPARE TO ACTIVE INGREDIENT OF
BAYER ® LOW DOSE ASPIRIN*
- Aspirin (NSAID) 81 mg
60 coated tablets
- Aspirin (NSAID) 81 mg
- INGREDIENTS AND APPEARANCE
aspirin tablet, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0015 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 - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) 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 1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0015-6 1 in 1 CARTON 07/01/2016 1 60 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 not final part343 07/01/2016 Labeler - SPIRIT PHARMACEUTICALS LLC (179621011) Establishment Name Address ID/FEI Business Operations ELYSIUM PHARMACEUTICALS LTD 915664486 manufacture(68210-0015)