EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]

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EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]
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NDC 51013-172-15, 51013-172-25, 51013-172-43
Set ID 7aae8651-d4ba-46e8-82e1-28bee0f66caa
Category HUMAN OTC DRUG LABEL
Packager PuraCap Pharmaceutical LLC
Generic Name
Product Class
Product Number
Application Number PART343
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    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

    • do not take more than directed (see Overdose warning)

    adults and children 12 years and over
    • take 2 softgels every 6 hours while symptoms last
    • do not take more than 6 softgels 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

    • store at room temperature 15°-30°C (59°-86°F)
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

  • Questions or Comments?

    Call : 1-888-309-9030

  • PRINCIPAL DISPLAY PANEL - Bottle Label 20ct

    DG Extra Strength Pain Reliever 20 Softgels

    Acetaminophen 500mg

    NDC 51013-172-15

    *Compare to the active ingredient in TYLENOL® Extra Strength

    Bottle Label 20ct Front

    Bottle Label 20ct Back

  • PRINCIPAL DISPLAY PANEL - Bottle Label 40ct

    DG Extra Strength Pain Reliever 40 Softgels

    Acetaminophen 500mg

    NDC 51013-172-25

    *Compare to the active ingredient in TYLENOL® Extra Strength

    Bottle Label 40ct Front

    Bottle Label 40ct Back

  • PRINCIPAL DISPLAY PANEL - Bottle Label 24ct

    DG Extra Strength Pain Reliever 24 Softgels

    Acetaminophen 500mg

    NDC 51013-172-43

    *Compare to the active ingredient in TYLENOL® Extra Strength

    Bottle Label 24ct Front

    Bottle Label 24ct Back

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-172
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Colorred (clear) Scoreno score
    Shapecapsule (oblong) Size27mm
    FlavorImprint Code PC24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-172-1520 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2016
    2NDC:51013-172-2540 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2016
    3NDC:51013-172-4324 in 1 BOTTLE; Type 0: Not a Combination Product08/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/08/2016
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-172) , analysis(51013-172)
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