Label: NOBLEAID PAIN RELIEVER- aspirin tablet, delayed release

  • NDC Code(s): 81533-600-10, 81533-600-11, 81533-600-30
  • Packager: Noble Otc LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 19, 2022

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

  • Drug Facts

  • Active Ingredient (in each tablet)

    Aspirin 81 mg (NSAID)

  • Purpose

    Pain Reliever

  • Uses

    For the temporary relief of minor aches and pains

  • WARNING

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use 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 non prescription 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 you are allergic 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

    Ask a doctor or pharmacist before use if you are taking a prescription drug for •gout •diabetes •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 •redness or swelling is present •fever lasts more than 3 days •new symptoms occur ringing in the ears or 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.

    KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions:

    •Drink a full glass of water with each dose •adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours •children under 12 years: consult a doctor.

  • Other Information:

    Store at room temperature

  • Inactive ingredients:

    Microcrystalline Cellulose, Silicon dioxide, Talcum, Croscarmellose sodium, Stearic acid, Colloidal silicon dioxide, Titanium dioxide, Triethyl citrate, Methacrylic acid copolymer, D&C Yellow #10, FD&C Yellow #6

  • SPL UNCLASSIFIED SECTION

    • Safe pain relief

    • Safety enteric-coated aspirin regimen

    ADULT LOW DOSE

    Compare to Bayer® Aspirin active ingredient

    Questions or comments?

    Please call (347)378-8990 Monday Through Friday 9-5 or by Email Info@nobleotc.com

    This product is not manufactured or distributed by Bayer Healthcare, LLC owner of the Registered Trademark BAYER® Tablets

    TAMPER EVIDENT Do not use if safety seal under cap is broken or missing.

    Manufactured for

    Noble OTC LLC

    Perth Amboy, NJ 08861

    www.nobleotc.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    NOBLEAID PAIN RELIEVER 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81533-600
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81533-600-10100 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2021
    2NDC:81533-600-11300 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2021
    3NDC:81533-600-301000 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/15/2021
    Labeler - Noble Otc LLC (041836435)