Label: VAZALORE- aspirin capsule

  • NDC Code(s): 73089-081-12, 73089-081-14, 73089-081-21
  • Packager: PLx Pharma Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 5, 2023

If you are a consumer or patient please visit this version.

  • 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
    • n ask your doctor about other uses of aspirin capsules
  • 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

    n hives n facial wseelling n shock n 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
  • ACTIVE INGREDIENT

    Active Ingredient (in Each capsules)

    Aspirin (NSAID)* 325mg

    *Non steroidal Anti inflammatory Drug

  • ASK 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
  • DO NOT USE

    Do not use If you have ever had an allergic reaction to aspirin or any other pain reliever / fever reducer

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or a pharmacist before you use if you are

    • Taking a drug for diabetes, gout or arthritis
  • Stop use and ask a doctor

    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

    - Feel faint - vomit blood - have bloody or black stool - 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
  • KEEP 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

  • PREGNANCY OR BREAST FEEDING

    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

  • PURPOSE

    Purposes:

    Aspirin (NSAID)* 325mg __ Pain reliever / fever reducer

    *Non steroidal Anti inflammatory Drug

  • Questions or Comments

    Questions or comments?

    Call 1-888-842-3569 9:00 AM – 7:00 PM ET, Monday – Friday

    RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION

  • 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
  • INACTIVE INGREDIENT

    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

  • 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
  • 30 Count Blister Carton

    30 CT Bottle Carton

  • 30 Count Bottle Label

    30 CT Bottle Label

  • 4 Count Blister Card

    4 ct blister card

  • 4 Count Blister Carton

    4 Ct Blister Carton

  • 12 Count Blister Carton

    12 Ct Blister Carton

  • INGREDIENTS AND APPEARANCE
    VAZALORE 
    aspirin capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73089-081
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg  in 81 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (White with Blue Band and A81 Imprint) Scoreno score
    ShapeCAPSULE (White Capsule with Blue Band and A81 Imprint) Size14mm
    FlavorImprint Code A81
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73089-081-211 in 1 CARTON08/05/2021
    181 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:73089-081-121 in 1 CARTON08/05/2021
    281 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:73089-081-1481 mg in 1 CARTON; Type 0: Not a Combination Product08/05/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20369708/05/2021
    Labeler - PLx Pharma Inc (079325568)
    Registrant - PLx Pharma Inc (079325568)