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| Product NDC Code | 10135-729 | ||||
|---|---|---|---|---|---|
| Drug Name | Aspirin |
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| 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] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 308416 | ||||
| Application Number | M013 | ||||
| Labeler Name | Marlex Pharmaceuticals Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Aspirin 81mg (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 years: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Corn Starch, Pregelatinized Starch, Povidone, Microcrystalline Cellulose, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, Silica, Sodium bicarbonate, Sodium lauryl sulfate, D&C Yellow #10, Hypromellose, Triacetin
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 relieves 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 Aspirin TITANIUM DIOXIDE D&C YELLOW NO. 10 SODIUM BICARBONATE SODIUM LAURYL SULFATE STARCH, CORN MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) TRIETHYL CITRATE SILICON DIOXIDE TRIACETIN POVIDONE, UNSPECIFIED STEARIC ACID HYPROMELLOSE, UNSPECIFIED TALC ASPIRIN ASPIRIN S;17
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 Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev.1 09/21 AA www.marlexpharm.com NDC 10135-0729-62 Label Front Label Back
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 Fact
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 · You have not been drinking fluids · You have lost a lot of fluid due to vomiting or diarrhea
Stop use and ask a doctor if · You experience any of the following signs of stomach bleeding · Feel faint · Have bloody or black stools · Vomit blood · 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 a loss of hearing occurs
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 a 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
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 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? Adverse Drug Event Call: (888) 582 1953 or Email: [email protected]
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 problem in the unborn child or complications during delivery.
Storage and handling
Information about safe storage and handling of the drug product.Other Information: · Store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F) · Use by expiration date on package
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 · Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) · Have 3 or more alcoholic drinks every day while using this product · Take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer 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 · You have not been drinking fluids · You have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or a 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 Stop use and ask a doctor if · You experience any of the following signs of stomach bleeding · Feel faint · Have bloody or black stools · Vomit blood · 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 a 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 problem in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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