VALUMEDS EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [SPIRIT PHARMACEUTICALS LLC]

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  • VALUMEDS EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [SPIRIT PHARMACEUTICALS LLC]

VALUMEDS EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [SPIRIT PHARMACEUTICALS LLC]
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NDC 68210-0130-1
Set ID 72a8bc52-3864-4e3d-8659-eef2d959bdf9
Category HUMAN OTC DRUG LABEL
Packager SPIRIT PHARMACEUTICALS LLC
Generic Name
Product Class
Product Number
Application Number PART343
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • WARNINGS

    Warnings

  • Liver Warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

  • Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Overdose Warning

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    do not take more than directed (see overdose warning)
    adults and children 12 years and over

    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

    children under 12 years

    • ask a doctor
  • Other information

    • each caplet contains: magnesium 0.43 mg
    • store between 20-25°C (68-77°F)

  • Inactive ingredients

    Hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed By

    Spirit Pharmaceuticals, LLC

    Ronkonkoma, NY 11779

  • PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle

    VALUMEDS

    EXTRA STRENGTH

    PAIN

    RELIEF

    ACETAMINOPHEN 500 mg


    PAIN RELIVER/FEVER REDUCER

    100 CAPLETS

    image description

  • INGREDIENTS AND APPEARANCE
    VALUMEDS EXTRA STRENGTH PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code S500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0130-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/15/2017
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LTD915664486manufacture(68210-0130)
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