Active Ingredient
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Careall Aspirin Tablet, Chewable
FDA Label NDC 51824-057
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Aspirin (NDC 51824-057). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children., uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever / fever reducer
Keep Out Of Reach Of Children.
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
Uses
Temporary relief of minor aches and pains or as recommended by your doctor. To reduce fever.
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 the user:
-Has had stomach ulcers or bleeding problems
-Takes a blood thinning (anticoagulant) or steroid drug
-Takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
-Takes more or for a longer time than directed
-Is age 60 or older
-Has 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.
Ask a doctor before use if:
-Stomach bleeding warning applies to user
-user has history of stomach problems, such as heartburn
-User has high blood pressure, heart disease, liver cirrhosis, or kidney disease
-User is 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:
-User experiences any of the following signs of stomach bleeding: feels faint, vomits blood, has bloody or black stools, 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
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: consult a doctor
Inactive Ingredients
corn starch, dextrates, FD C yellow 6, flavor, saccharin sodium
* Please review the disclaimer below.
