Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 49483-341-01, 49483-341-10, 49483-341-20, 49483-341-50
  • Packager: TIME CAP LABS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)
    Acetaminophen 500 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    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

    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

    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 DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

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

  • STOP USE

    Stop using 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.

  • 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 (1-800-222-1222) right away. 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 waning)
    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 take for more than 10 days unless directed by a doctor
    children under 12 years: ask a doctor

  • OTHER INFORMATION

    Other information

    • SODIUM FREE
    • store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycloate*, stearic acid, titanium dioxide
    *may contain this ingredient

  • QUESTIONS

    Questions or comments?Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    341R-Timely-APAP500-200s-label341R-Timely-APAP-500s-label341R-Timely-Acetaminophen 500mg-bottle label-1000s341R-Timely-Acetaminophen 500mg-bottle label-100s

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-341
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL ((caplet)) Size17mm
    FlavorImprint Code TCL341
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-341-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-341-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2021
    3NDC:49483-341-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/20/2022
    4NDC:49483-341-20200 in 1 BOTTLE; Type 0: Not a Combination Product10/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/18/2011
    Labeler - TIME CAP LABS INC (037052099)
    Registrant - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABS INC037052099manufacture(49483-341)
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