Label: NATURAL ASPIRIN PLUS IMMUNE SUPPORTING DIETARY SUPPLEMENT- aspirin kit

  • NDC Code(s): 73678-103-01
  • Packager: Applied Biological Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 28, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever and fever reducer

  • Uses

    For temporary relief of minor aches and pain associated with chills, headache, body aches, fever, and sore throat.

  • 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, asthma (wheezing), shock.

    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 allergic to milk, egg, wintergreen oil, and/or menthol, or have ever had an allergic reaction to this product or any of its ingredients.

    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 have asthma, you are taking a diuretic.

    Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation, diabetes, gout or arthritis.

    Stop use and ask a doctor if: an allergic reaction occurs. Seek medical help right away. • you experience 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 • new symptoms occur • ringing in the ears or a loss or 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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Drink a full glass of water with each dose
    • Adults and children 12 years and over: Take 1 to 2 tablets every 4 hours while symptoms last
    • Do not take more than 12 tablets in 24 hours unless directed by a doctor
    • Children under 12 years: do not use unless directed by a doctor
  • Inactive ingredients

    Bamboo extract, calcium carbonate, coconut oil, dicalcium phosphate, maize starch, pectin, sodium alginate, stearic acid, sugar, sunflower lecithin

  • SPL UNCLASSIFIED SECTION

    biovanta ®

    (NSAID*) Non-Drowsy | Sugar Free

    MULTI-SYMPTOM RELIEF COLD

    FOR PAIN RELIEF ASSOCIATED WITH: Chills, Headache, Fever, and Sore Throat

    TAKE TABLET

    1. Take Tablet to Treat Symptoms

    4 TABLETS

    Questions or Comments?

    866-889-3959

    info@appliedbioinc.com

    Distributed by:

    Applied Biological Laboratories

    760 Parkside Ave., 317

    Brooklyn, New York 11226

  • SPL UNCLASSIFIED SECTION

    IMMUNE-SUPPORTING* SPRAY

    USE SPRAY

    DIETARY SUPPLEMENT

    2. Use Spray to Help Support Immunity

    Net Wt. 10 mL (.338 fl oz)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    NATURAL ASPIRIN PLUS IMMUNE SUPPORTING DIETARY SUPPLEMENT 
    aspirin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73678-103
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73678-103-011 in 1 KIT; Type 0: Not a Combination Product04/25/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BLISTER PACK
    Part 1 of 1
    NATURAL ASPIRIN 
    aspirin tablet
    Product Information
    Item Code (Source)NDC:73678-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PECTIN (UNII: 89NA02M4RX)  
    SUCROSE (UNII: C151H8M554)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/25/2023
    Labeler - Applied Biological Laboratories Inc. (080512733)