DURALGINA (ACETAMINOPHEN) TABLET [MENPER DISTRIBUTORS INC.]

DURALGINA (ACETAMINOPHEN) TABLET [MENPER DISTRIBUTORS INC.]
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NDC 53145-013-71
Set ID bb31f66c-80a9-4bdb-983b-cef5d21de5ff
Category HUMAN OTC DRUG LABEL
Packager Menper Distributors Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    Acetaminophen 325 mg

  • PURPOSE

    Purpose

    Pain reliever/Fever reducer

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains associated with 

    • headache
    • muscular aches
    • minor arthritis pain
    • menstrual cramps
    • common cold
    • temporarily reduces fever
    • backaches
    • toothaches
  • WARNINGS

    Warnings:

    Liver warning:

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

    • more than12 tablets in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day.

    Do not use:

    • with any other drug conatining acetaminophen (prescription or non-prescription). 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 the product.

    Ask a doctor before use if you have liver disease

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

    Stop using this product 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 persistent
    • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Do not take more than directed (see overdose warning)
     Adults and children12 years and over Take 2 tablets every 4-6 hours as needed. Do not take more than 12 tablets in 24 hours, unless directed by a doctor
     Children ages 6-11 Take 1 tablet every 4-6 hours as needed. Do not take more than 6 tablets in 24 hours, unless directed by a doctor
     Under 6 years of age Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients Magnesium stearate, povidone, silicone dioxide, sodium carboxymethyl, starch, stearic acid

  • QUESTIONS

    Questions: Call 1-800-560-5223 M-F 9AM - 4PM Eastern

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DURALGINA 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 555
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-013-7130 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/2017
    Labeler - Menper Distributors Inc. (101947166)
    Registrant - Menper Distributors Inc. (101947166)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lex Inc.046172888manufacture(53145-013)

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