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Aspirin 81 mg - Medication Information

Product NDC Code 69618-014
Drug Name

Aspirin 81 mg

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 part343
Labeler Name Reliable 1 Laboratories LLC
Packages
Package NDC Code Description
69618-014-36 36 tablet, chewable in 1 bottle, plastic (69618-014-36)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each tablet) Aspirin USP 81 mg (NSAID)* *nonsterodial 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 & older: take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours children under 12 years: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients compressible sugar, corn starch, FD&C yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide

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 temporarily relieaves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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.
Aspirin 81 mg Aspirin ASPIRIN ASPIRIN STARCH, CORN SILICON DIOXIDE SUCROSE FD&C YELLOW NO. 6 MAGNESIUM STEARATE AP;009

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.
NDC 69618-014-36 ORANGE FLAVORED Aspirin USP 81 mg (NSAID) Adult Low Strength PAIN RELIEVER 36 CHEWABLE TABLETS *Compare to Active Ingredient in Aspirin Regimen BAYER® Chewable Aspirin 81 mg chew

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drugs Facts Allergy alert: Aspirin may cause a severe allergic reastion which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains an NSID, 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 steriod drug take other drugs containing prescription or non-prescription NSAIDs (ibuprofen, naproxen, or others) take more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product Drug Facts continued on back of label TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BAYER®. Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580 www.reliable1labs.com

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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 are taking a diuretic you have asthma

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout or arthritis under a doctor's care for any serious condition taking any other drug

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer for at least 7 days after tonsillectomy or oral surgery

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. Incase of overdose, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if 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 pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear ringing in the ears or loss of hearing occurs These could be sings of a serious condition

Storage and handling

Information about safe storage and handling of the drug product.
Other infomation Store at room temperature 15º-30ºC (59º-86ºF)

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 chould be an early sign of Reye's syndrome, a rare but serious illness.

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