EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [SPIRIT PHARMACEUTICAL LLC]

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  • EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [SPIRIT PHARMACEUTICAL LLC]

EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [SPIRIT PHARMACEUTICAL LLC]
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NDC 68210-0013-1, 68210-0013-2, 68210-0013-5
Set ID 4e43cb22-b154-4e20-832f-c17277e30aae
Category HUMAN OTC DRUG LABEL
Packager Spirit Pharmaceutical 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

    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 a doctor before use if you have liver disease

    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.

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

    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

    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 yearsask a doctor
  • Other information

    • each caplet contains: magnesium 0.43 mg
    • store between 20-25°C (68-77°F)
    • do not use if carton is opened or inner Safety Seal is broken or missing
  • 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:
    FAMILY DOLLAR SERVICES, INC.,
    10401 MONROE RD,
    MATTHEWS, NC 28105 USA

  • PRINCIPAL DISPLAY PANEL - ACETAMINOPHEN 500MG CARTON

    FAMILYwellness™

    COMPARE TO THE ACTIVE
    INGREDIENT OF EXTRA
    STRENGTH TYLENOL® CAPLETS*

    100% SATISFACTION
    OR YOUR MONEY BACK
    GUARANTEED

    Extra Strength
    Acetaminophen
    Pain Reliever/Fever Reducer
    Contains No Aspirin

    50 CAPLETS - 500 mg
    ACTUAL SIZE

    image description

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0013
    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, UNSPECIFIED (UNII: FZ989GH94E)  
    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:68210-0013-51 in 1 CARTON08/12/2016
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68210-0013-11 in 1 CARTON08/12/2016
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68210-0013-21 in 1 CARTON08/12/2016
    3250 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:68210-0013-41 in 1 CARTON02/12/2020
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/12/2016
    Labeler - Spirit Pharmaceutical LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LTD915664486manufacture(68210-0013)
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