Label: VALUMEDS ASPIRIN- aspirin tablet, delayed release

  • NDC Code(s): 68210-0025-0
  • Packager: SPIRIT PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 April 18, 2018

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

  • Active ingredient (in each tablet)

    Aspirin (NSAID)* 325 mg

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • INDICATIONS & USAGE

    • temporary relieves minor aches and pains due to: 
    • headache 
    • minor arthritis pain
    • toothache
    • menstrual pain
    • colds
    •  or as recommended by a doctor
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  • 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.
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  • Do not use

    if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

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  • 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
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  • Ask a doctor or phamracist before use if you are

    taking a prescription drug for diabetis, gout or arthritis

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  • 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.

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  • 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.

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  • 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

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  • 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
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  • Other information

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

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  • Questions or comments?

    1(888)333-9792

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  • 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

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  • INGREDIENTS AND APPEARANCE
    VALUMEDS ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0025
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color orange Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-0025-0 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/17/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 04/17/2018
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABORATORIES, INC. 037052099 manufacture(68210-0025)
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