Label: LOW DOSE ASPIRIN- aspirin 81 mg delayed release tablets tablet
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NDC Code(s):
0363-0690-12,
0363-0690-20,
0363-0690-29,
0363-0690-31, view more0363-0690-32
- Packager: WALGREENS
- 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 May 21, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 problem
- take a blood thinning (anticoagulant) or steroid drug
- take other drug 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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
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STOP USE
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
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
ringing in the ears or a loss of hearing occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LOW DOSE ASPIRIN
aspirin 81 mg delayed release tablets tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0690 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 DIMETHICONE (UNII: 92RU3N3Y1O) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM HYDROXIDE (UNII: 55X04QC32I) FERRIC OXIDE RED (UNII: 1K09F3G675) TALC (UNII: 7SEV7J4R1U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code Heart Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0690-12 1 in 1 CARTON 10/08/2021 1 120 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-0690-32 1 in 1 CARTON 06/15/2022 2 32 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-0690-29 2 in 1 CARTON 06/15/2022 3 120 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0363-0690-20 1 in 1 CARTON 06/15/2022 4 200 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0363-0690-31 1 in 1 CARTON 06/15/2022 5 300 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 10/08/2021 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(0363-0690)