Label: NEO-LUBRINA FUERTE- acetaminophen, caffeine tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 9, 2023

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  • Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Caffeine 65 mg

  • Purposes

    Pain reliever

    Pain reliever aid

  • Uses

    • temporarily relieves minor aches and pain due to:
    • headache
    • muscular aches
  • Warnings

    Liver warning

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

    • more than 6 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Caffeine warning

    The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

    Ask a doctor before use if

    you have liver disease

    Ask a doctor or pharmacist

    if you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • any new symptoms occur
    • symptoms do not get better or worsen
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. 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 exceed recommended dosage
    • adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 6 caplets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, polyvinylpyrrolidone, stearic acid, talc, titanium dioxide.

  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

  • Principal Display Panel

    NDC 69729-149-24

    Neo-Lubrina Fuerte

    24 Caplets

    NeoLubrina Fuerte

  • INGREDIENTS AND APPEARANCE
    NEO-LUBRINA FUERTE 
    acetaminophen, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-149
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL ((Caplet)) Size17mm
    FlavorImprint Code 5431
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-149-242 in 1 CARTON08/09/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/09/2023
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LIMITED915664486label(69729-149) , manufacture(69729-149) , pack(69729-149)
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