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| Product NDC Code | 73089-325 | ||||
|---|---|---|---|---|---|
| Drug Name | Vazalore |
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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 | CAPSULE | ||||
| RxCUI drug identifier | 198466, 2563428 |
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| Application Number | NDA203697 | ||||
| Labeler Name | PLx Pharma 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 Active Ingredient (in Each capsules) Purposes: Aspirin (NSAID)* 325mg __ Pain reliever / fever reducer *Non steroidal 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 Directions Drink a full glass of water with each dose Adults and children 12 years and over: Take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist Do not exceed 12 capsules in 24 hours Children under 12 years consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C blue #1, Hypromellose, lecithin, oleic acid, pharmaceutical ink, potassium chloride, soybean 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.Uses Uses For temporary relief of minor aches and pains associated with: headache Backache muscular aches a cold toothache minor pains of arthritis premenstrual and menstrual cramps temporarily redices fever ask your doctor about other uses of aspirin capsules
Purpose
Information about the drug product’s indications for use.Active Ingredient (in Each capsules) Purposes: Aspirin (NSAID)* 325mg __ Pain reliever / fever reducer *Non steroidal Anti inflammatory Drug
Spl product data elements
Usually a list of ingredients in a drug product.VAZALORE aspirin .IOTA.-CARRAGEENAN LECITHIN, SOYBEAN TITANIUM DIOXIDE POTASSIUM CHLORIDE FD&C BLUE NO. 1 ASPIRIN ASPIRIN ANHYDROUS CITRIC ACID SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED OLEIC ACID White Capsule with Blue Band and VAX325 VAZ325 White capsules with blue band and VAZ325
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.VALAZORE (aspirin) Capsules 325 mg Bottle 325 mg Carton
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.None
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 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 a pharmacist Ask a doctor or a pharmacist before you use if you are Taking a drug for diabetes, gout or arthritis
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 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
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.Keet out of Reach of Children 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 1-888-842-3569 9:00 AM – 7:00 PM ET, Monday – Friday RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION
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.Do not use I f you have ever had an allergic reaction to aspirin or any other pain reliever / fever reducer Stop use and ask a doctor if An allergic reaction occurs. Seek medical help right away You experience amu of the following signs of stomach bleeding n Feel faint n vomit blood n have bloody or black stool n 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 Ringing in the ears or loss of hearing occurs Redness and swelling is present in the painful area Any new symptoms occur. These could be signs of serious conditions
Pregnancy or breast feeding
Pregnancy or Breast feedingOregnancy or Breastfeeding If pregnant or breast feeding , ask a healthcare 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
Storage and handling
Information about safe storage and handling of the drug product.Other Information Other Information Save carton for full directions and warnings Store at 15-30°C (59-86°F) Avoid excessive heat above 40°C (104°F) Do not use if the blue band around the capsule is missing or broken
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 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 wseelling - shock - astham (wheezing) This product contains soy Stomach bleeding warning: This product contains an NSAID, which may cause 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
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