Label: VAZALORE- aspirin capsule
- NDC Code(s): 73089-325-21
- Packager: PLx Pharma Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 5, 2023
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- ACTIVE iNGREDIENT
- Ask a doctor
- Ask a doctor or a pharmacist
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DO NOT USE
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
- Keet out of Reach of Children
- Oregnancy or Breastfeeding
- PURPOSE
- QUESTIONS
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STOP USE
Do not use If 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
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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
- Directions
- Other Information
- INACTIVE INGREDIENT
- Uses
- VALAZORE (aspirin) Capsules
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INGREDIENTS AND APPEARANCE
VAZALORE
aspirin capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73089-325 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg in 325 mg Inactive Ingredients Ingredient Name Strength .IOTA.-CARRAGEENAN (UNII: 3582R1F52W) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POTASSIUM CHLORIDE (UNII: 660YQ98I10) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) OLEIC ACID (UNII: 2UMI9U37CP) Product Characteristics Color white (White capsules with blue band and VAZ325) Score no score Shape CAPSULE (White Capsule with Blue Band and VAX325) Size 23mm Flavor Imprint Code VAZ325 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73089-325-21 1 in 1 CARTON 08/05/2021 1 325 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203697 08/05/2021 Labeler - PLx Pharma Inc (079325568) Registrant - PLx Pharma Inc (079325568)