VALUMEDS ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [SPIRIT PHARMACEUTICALS LLC]

VALUMEDS ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [SPIRIT PHARMACEUTICALS LLC]
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NDC 68210-0025-0
Set ID 9efd2b0e-64f0-4ca2-bce3-075f08312096
Category HUMAN OTC DRUG LABEL
Packager SPIRIT PHARMACEUTICALS LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each tablet)

    Aspirin (NSAID)* 325 mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • INDICATIONS & USAGE

    • temporary relieves minor aches and pains due to: 
    • headache 
    • minor arthritis pain
    • toothache
    • menstrual pain
    • colds
    •  or as recommended by a doctor
  • 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
    • shock
    • facial swelling
    • asthma (wheezing)

    Stomach bleeding warning:  This product contains an NSAID, which may cause  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 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
  • Ask a doctor or phamracist before use if you are

    taking a prescription drug for diabetis, gout or arthritis

  • Stop use and ask a doctor if

    • 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
    • any new symptom appear
    • ringing in the ears or a loss of hearing occurs

    These could be signs of a serious condition.

  • 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 right away. 1(800)222-1222

  • Directions

    • adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
    •  do not take more than 12 tablets in 24 hours unless directed by a doctor
    •  children under 12 years of age: ask a doctor
  • Other information

    • store below 25 0C (77 0F)
    • Tampet Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken
  • INACTIVE INGREDIENT

    corn starch, croscarmellose sodium,D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc,titanium dioxide, triethyl citrate

  • Questions or comments?

    1(888)333-9792

  • PRINCIPAL DISPLAY PANEL

    VALUMEDS TM

    Compare to the active ingredient in

    ECOTRIN ® TABLETS*

    REGULAR STRENGTH

    ASPIRIN

    PAIN RELIEVER (NSAID)

    • SAFETY COATED

    PROTECT AGAINST

    STOMACH UPSET

    500 TABLETS


    aspirin 325 mg

  • INGREDIENTS AND APPEARANCE
    VALUMEDS ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0025-0500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34304/17/2018
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(68210-0025)

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