Label: ACETAMINOPHEN tablet

  • NDC Code(s): 49483-340-01, 49483-340-10
  • Packager: TIME CAP LABS INC
  • 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 March 28, 2023

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Acetaminophen 325 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains due to:

    headache

    muscular aches

    backache

    minor pain of arthritis

    the common cold

    toothache

    premenstrual and menstrual cramps

    • temporarily reduces fever

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 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 the user has liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

  • STOP USE

    Stop use and ask a doctor if
    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • 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 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 children 12 years and over
    • take 2 tablets every 4 to 6 hours while symptoms last
    • do not take more than 10 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children 6 years to under 12 years
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by a doctor
    children under 6 years
    • ask a doctor

  • OTHER INFORMATION

    Other information

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

    Inactive ingredients
    povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
    *may contain this ingredient

  • PRINCIPAL DISPLAY PANEL

    340R-Timely-APAP-1000s-label340R-Timely-APAP-100s-label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-340
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL340
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-340-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-340-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/15/2011
    Labeler - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABS INC037052099manufacture(49483-340)