Label: ASPIRIN tablet, delayed release
- NDC Code(s): 36800-545-60
- Packager: Topco Associates, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 26, 2024
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 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
- shock
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
- are age 60 or older
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- you are taking a diuretic
- 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 have asthma
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:
- vomit blood
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- vomit blood
- ringing in the ears or a loss of hearing occurs
- 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
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
NDC 36800-545-60
TopCare
health®COMPARE TO ST. JOSEPH® LOW DOSE SAFETY
COATED 81 mg ASPIRIN ACTIVE INGREDIENT†LOW DOSE ♥ ASPIRIN REGIMEN**
Aspirin 81 mg
PAIN RELIEVER (NSAID)
Safety Coated**Talk to your doctor or other healthcare provider
before using this product for your heart.actual size
180 ENTERIC COATED TABLETS
†This product is not manufactured or distributed by Foundation
Consumer Healthcare, LLC, owner of the registered trademark
St. Joseph® Low Dose Safety Coated 81 mg Aspirin.
50844 REV0122A64560DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA1220
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.comThis TopCare® product is laboratory
tested to guarantee its highest quality.
Your total satisfaction is guaranteed.TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGTopcare 44-645
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-545 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHACRYLIC ACID (UNII: 1CS02G8656) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color pink Score no score Shape ROUND Size 6mm Flavor Imprint Code L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-545-60 1 in 1 CARTON 03/19/2021 1 180 in 1 BOTTLE, PLASTIC; 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 03/19/2021 Labeler - Topco Associates, LLC (006935977) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(36800-545) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(36800-545) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(36800-545) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(36800-545) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(36800-545) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(36800-545)