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Product NDC Code | 51662-1583 | ||||
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Drug Name | Aspirn |
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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] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET, FILM COATED | ||||
RxCUI drug identifier | 212033 | ||||
Application Number | M013 | ||||
Labeler Name | HF Acquisition Co LLC, DBA HealthFirst | ||||
Packages |
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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.do not take more than directed ■ the smallest effective dose should be used ■ do not take longer than 10 days, unless directed by a doctor (see Warnings) ■ drink a full glass of water with each dose Adults and children: Take 1 or 2 tablets with water every 4 hours as needed. Do not (12 years and older) take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium 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.do not take more than directed ■ the smallest effective dose should be used ■ do not take longer than 10 days, unless directed by a doctor (see Warnings) ■ drink a full glass of water with each dose Adults and children: Take 1 or 2 tablets with water every 4 hours as needed. Do not (12 years and older) take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.
Purpose
Information about the drug product’s indications for use.Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.ASPIRN ASPIRIN ASPIRIN ASPIRIN CROSCARMELLOSE SODIUM MINERAL OIL TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES STARCH, CORN Aspirin;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.SERIALIZED LABEL
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.DRUG FACTS Active ingredient (in each tablet) Aspirin (NSAID*) 325 mg *nonsteroidal anti-inflammatory drug
USES Temporarily relieves minor aches and pains associated with ■ headache ■ minor arthritis pain ■ common cold ■ menstrual cramps ■ muscular aches ■ backache ■ toothache Temporarily reduces fever.
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.■ 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.■ 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.■ if you have ever had an allergic reaction to any other pain reliever/ fever reducer ■ right before or after heart surgery ■ if you are taking prescription drugs for gout, diabetes or arthritis
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.In case of overdose, get medical help or contact a Poison Control Center right away.
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.■ 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 ■ you have difficulty swallowing ■ if ringing in the ears or loss of hearing occurs ■ redness or swelling is present in the painful area ■ any new symptoms appear
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.take with food or milk if stomach upset occurs
Pregnancy or breast feeding
Pregnancy or Breast feedingask 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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.1 (2 Pack) 325 NSAID
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.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 ■ skin reddening ■ facial swelling ■ rash ■ asthma (wheezing) ■ blisters ■ shock If an allergic reaction occurs, stop use and seek medical help right away. 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 ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcohol drinks every day while using this product ■ take more or for a longer time than directed
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