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Careall aspirin - Medication Information

Product NDC Code 51824-057
Drug Name

Careall aspirin

Type Brand
Pharm Class Anti-Inflammatory Agents,
Non-Steroidal [CS],
Cyclooxygenase Inhibitors [MoA],
Decreased Platelet Aggregation [PE],
Decreased Prostaglandin Production [PE],
Nonsteroidal Anti-inflammatory Drug [EPC],
Platelet Aggregation Inhibitor [EPC]
Active Ingredients
Aspirin 81 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 318272
Application Number M013
Labeler Name New World Imports, Inc
Packages
Package NDC Code Description
51824-057-36 36 tablet, chewable in 1 bottle (51824-057-36)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients corn starch, dextrates, FD C yellow 6 aluminum lake, orange flavor, saccharin sodium

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses for the temporary relief of minor aches and paines or as recommended by your doctor

Purpose

Information about the drug product’s indications for use.
Purpose Pain reliever

Spl product data elements

Usually a list of ingredients in a drug product.
CAREALL Aspirin Aspirin Aspirin Aspirin Dextrates Saccharin Sodium Starch, Corn FD&C YELLOW NO. 6 Pale Orange Round AZ;013

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
CCA36 Label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of accidental overdose, get medical help or contact aPoison Control Center (1-800-222-1222) right away

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 p regnant 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API