Label: CAREALL ASPIRIN- aspirin tablet, chewable
- NDC Code(s): 51824-057-36
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Keep out of reach of children.
- Uses
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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 NSAID, which may cause severe stomach bleeding. The chance is higher if you:
-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)
-Take more or for a longer time than directed
-Are age 60 or older
-Have 3 or more alcoholic drinks every day while using this product
Do not use:
-if you are allergic to aspirin or other pain relievers / fever reducers
-For at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
-If you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if:
-Stomach bleeding warning applies to user
-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
Ask a doctor of pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis.
Stop use and ask a doctor if:
-You experience any of the following signs of stomach bleeding: feel faint, vomit blood, has bloody or black stool, has stomach pain that does not get better
-An allergic reaction occurs. Seek medical help help right away
-New symptoms occur
-Redness or swelling is present
-Pain gets worse or lasts for more than 10 days
-Ringing in the ears or loss of hearing occurs
-You may report side effects to 1-888-952-0050
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 specifically directed to do so by a doctor because it may cause problems in unborn child or complications during delivery.
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-057 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 Dextrates (UNII: G263MI44RU) Saccharin Sodium (UNII: SB8ZUX40TY) Starch, Corn (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color orange (Pale Orange) Score no score Shape ROUND (Round) Size 8mm Flavor Imprint Code AZ;013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-057-36 36 in 1 BOTTLE; Type 0: Not a Combination Product 03/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/29/2016 Labeler - New World Imports, Inc (075372276)