Label: TYLO EXTRA (ACETAMINOPHEN)- acetaminophen tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL

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 30, 2021

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  • Tylo Extra 1000 mg

    Drug Facts

  • Active Ingredient

    Acetaminophen 1000 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • backache
    • minor pain of arthritis
    • temporarily reduces fever
    • the common cold
    • toothache
    • menstrual cramps
    • muscular aches
  • 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.
  • Do not use

    • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you have ever had an allergic reaction 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 your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • STOP USE

    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 appear
    • 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

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 1 caplet every 6 to 8 hours
    • Do not take more than 4 caplets of this product in 24 hours.

    Children under 12 years:

    • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
  • Other information

    • store between 20-25°C (68-77°F)
    • see end panel for lot number and expiration date
  • Inactive ingredients

    • Povidone, Pregelatinized Starch, Crosspovidone Stearic Acid, Titanium Dioxide, Carnauba Wax Hypromellose, Polyethylene Glycol.
  • Questions or comments?

    call toll free 1-855-470-6722

  • Package Labeling:

    Label5Label6

  • INGREDIENTS AND APPEARANCE
    TYLO EXTRA (ACETAMINOPHEN) 
    acetaminophen tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49638-112-301 in 1 CARTON01/17/2019
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/17/2019
    Labeler - America Medic & Science, LLC (071065464)
    Registrant - America Medic & Science, LLC (071065464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elvi Pharma LLC.078739246manufacture(49638-112)
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