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Aspirin - Medication Information

Product NDC Code 55154-6755
Drug Name

Aspirin

Type Generic
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 325 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 212033
Labeler Name Cardinal Health 107, LLC
Packages
Package NDC Code Description
55154-6755-0 10 blister pack in 1 bag (55154-6755-0) / 1 tablet in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Aspirin 325 mg (in each tablet)

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 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor Children under 12 years: consult a doctor .

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients corn starch, Hypromellose, polyethylene glycol, propylene glycol

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 pains due to: • Headache • Colds • Menstrual pain • Muscle pain • Toothache • Minor pain of arthritis • Or as directed by your doctor

Purpose

Information about the drug product’s indications for use.
Purpose Pain Reliever / Fever Reducer

Spl product data elements

Usually a list of ingredients in a drug product.
Aspirin Aspirin ASPIRIN ASPIRIN STARCH, CORN CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE MINERAL OIL TITANIUM DIOXIDE 44;157

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.
Principal Display Panel ASPIRIN 325mg 10 MICRO-COATED TABLETS 325mg bag 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 Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information 1. Do not use if packet is torn, cut or opened. 2. Store at 25C (77F) excursions permitted between 15-30C (59-86F) 3. use by expiration date on package Mfg. by: Time-Cap Labs Inc., Farmingdale, NY 11735 Dist. By: Hospak® Unit Dose Products, Huntley, IL 60142 Rev. 08/17 Distributed By: Cardinal Health Dublin, OH 43017 L42652451223

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 • Shock • 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 • Have 3 or more alcoholic drinks every day while using this product • Take more or for a longer time than directed • Take other drugs containing prescription or nonprescription NSAIDS (aspirin, ibuprofen, naproxen, or others) Do not use - if you are allergic to aspirin or any other pain reliever/fever reducer, 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 you • You have a history of stomach problems, such as heartburn • You have asthma • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease • You are taking a diuretic • You have not been drinking fluids • You have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are • Taking a prescription drug for diabetes, gout or arthritis • Taking any other drug • Under a doctor’s care for any serious condition Warning: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Stop use and ask a doctor if -you experience any of the following signs of stomach bleeding 1. Feel faint 2. Have bloody or black stools 3. Vomit blood 4. have stomach pain that does not get better 5. pain get worse or lasts more than 10 days 6. fever gets worse or lasts more than 3 days 7. redness or swelling is present in the painful area 8. any new symptoms appear 9. 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.

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