Label: ASPIRIN ENTERIC SAFETY COATED- aspirin tablet
- NDC Code(s): 36800-030-18
- Packager: TOP CARE (Topco Associates 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 June 15, 2018
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- Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
Temporarily relieves minor aches and pains.Close
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:
- facial swelling
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 steroid drug
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- 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 have asthma
- you are taking a diuretic
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 help right away.
- you experience 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
- new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- ringing in the ears or 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 (1-800-222-222).
- 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: do not use unless directed by a doctor
- Other information
- store between 20-25ºC (68-77ºF)
- Inactive ingredients
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium,FD&C red # 40 aluminum lake,FD&C yellow # 6 aluminum lake, yellow iron oxide, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrateClose
- Questions or comments?
Call toll free 1-888-429-0139Close
- Principal Display Panel
COMPARE TO ST. JOSEPH LOW DOSE ASPIRIN ACTIVE INGREDIENT†
LOW DOSE ASPIRIN**
Aspirin 81 mg
PAIN RELIEVER (NSAID)
ENTERIC COATED TABLETS
**Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is not right for everyone.
±Coating helps protect against stomach upset
†This product is not manufactured or distributed by Foundation Consumer Healthcare LLC., distributor of St. Joseph® Low Dose Aspirin.
TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007Close
- Product Label
TOPCARE HEALTH Aspirin 81 mg
- INGREDIENTS AND APPEARANCE
ASPIRIN ENTERIC SAFETY COATED
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-030 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE RED (UNII: 1K09F3G675) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color ORANGE 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:36800-030-18 1 in 1 BOX 06/30/2014 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 NOT FINAL part343 06/30/2014 Labeler - TOP CARE (Topco Associates LLC) (006935977)