Label: ASPIRIN 81 MG- aspirin tablet, coated
- NDC Code(s): 69618-066-02, 69618-066-10
- Packager: Reliable 1 Laboratories LLC
- 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 August 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Reye's syndrome: Children and teenagers who have or are recoving 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 early sign of Reye's syndrome, a rare but serious illness.
- OTHER SAFETY INFORMATION
-
SPL UNCLASSIFIED SECTION
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 steriod drug
- take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for longer time than directed
- DO NOT USE
- ASK DOCTOR/PHARMACIST
-
STOP USE
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you are experierance 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 signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
-
Inactive ingredients
corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin.
-
ASK DOCTOR
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 drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea
- Drug Facts
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRIN 81 MG
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-066 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POVIDONE (UNII: FZ989GH94E) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color yellow Score no score Shape ROUND Size 5mm Flavor Imprint Code 17;S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69618-066-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2020 2 NDC:69618-066-02 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 10/01/2020 Labeler - Reliable 1 Laboratories LLC (079718111) Registrant - Reliable 1 Laboratories LLC (079718111)