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| Product NDC Code | 71610-034 | ||||
|---|---|---|---|---|---|
| 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 | 198467 | ||||
| Application Number | part343 | ||||
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC | ||||
| 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 325 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 : 1-2 tablets every 4 hours while symptoms last, but not more than 12 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 croscarmellose sodium, D&C Yellow #10 (Al-Lake), FD&C yellow #6 (Al-Lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, PVP, sodium lauryl sulfate, starch, stearic acid, talc, 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.Uses temporarily relieves headache menstrual pain muscle pain toothache minor pain or arthritis pain and fever of colds
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 CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 METHACRYLIC ACID POLYETHYLENE GLYCOL 1000 PROPYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE HYPROMELLOSES ASPIRIN ASPIRIN AP;011
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 - 325mg NDC 71610-034 - Aspirin EC (NSAID) 325mg - Rx Only Bottle Label 325mg
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.Other Information avoid excessive heat or humidity store at 15-30 °C (59-86 °F)
Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 325mg 100 71610-034-65 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20180218JH Aphena Pharma Solutions - TN
| Count | |
| 100 | 71610-034-65 |
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 or Comments Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742
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 signs of Reye’s syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include hives asthma (wheezing) shock facial swelling 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 takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others) takes more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product. Do not use if you have ever had an allergic reaction to 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, lever cirrhosis, or kidney disease you are taking a diuretic you have asthma 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 Stop use and ask a doctor if you experiences 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 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 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