Label: TOPCARE ASPIRIN- aspirin tablet, chewable
- NDC Code(s): 36800-259-68
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
temporarily relieves minor aches and painsClose
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
- asthma (wheezing)
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
- 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
Do not use
- if you have ever had an allergic reaction to any pain reliever/fever reducer
- for at least 7 days after tonsillectomy or oral surgery unless directed by a 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 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
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
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. (1-800-222-1222)
- drink a full glass of water with each dose
- adults and children 12 years and over take 4 to 8 tablets every 4 hours while symptoms persist.
Do not exceed 48 tablets in 24 hours or as directed by a doctor.
- children under 12 do not use unless directed by a doctor
- Other information
- store at 20º-25ºC (68º-77ºF)
- Inactive ingredients
corn starch, dextrose excipient, FD&C yellow #6 aluminum lake, flavors, saccharin sodiumClose
- Questions or comments?
- Principal Display Panel
ADULT LOW STRENGTH – ASPIRIN REGIMEN
Chewable - Orange Flavor
Aspirin 81 mg
Pain Reliever (NSAID)
COMPARE TO ST. JOSEPH® CHEWABLE ASPIRIN 81 mg active ingredientClose
- INGREDIENTS AND APPEARANCE
aspirin tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-259 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color ORANGE (Light Orange) Score no score Shape ROUND Size 8mm Flavor ORANGE Imprint Code L467 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-259-68 1 in 1 CARTON 1 36 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/28/2006 Labeler - Topco Associates LLC (006935977)