Label: XPECT ACETAMINOPHEN- acetaminophen tablet

  • NDC Code(s): 42961-399-01, 42961-399-04, 42961-399-05
  • Packager: Cintas Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to: headache, the common cold, backache, minor pain of arthritis, toothache, muscular aches, premenstrual and menstrual cramps
    • temporarily reduces fever   
  • 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

    • 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 a doctor before use if you have

    liver disease. 

  • Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin. 

  • 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 occur
    • redness or swelling is present 

    These could be signs of a serious condition. 

  • If pregnant or breast-feeding,

    ask a health professional before use. 

  • Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
    • adults and children 12 years and over: take 2 tablets every 6 hours while symptoms last; do not take more than 6 tablets 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

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see packet for expiration date and lot number
  • Inactive ingredients

    castor oil, corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, starch, steric acid, titanium dioxide

  • Questions?

    1-877-973-2811 Monday-Friday 8:00 AM-5:00 PM

  • Principal Display Panel - Wrapper

    MAXIMUM STRENGTH ACETAMINOPHEN

    Acetaminophen 500 mg • Pain Reliever/Fever Reducer

    2 TABLETS/PACKAGE 

    DO NOT USE IF PACKET IS DAMAGED OR OPEN

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    wrapper-01

  • Principal Display Panel - 100 count Box

    Compare to the active ingredients in Extra Strength Tylenol®*

    MAXIMUM STRENGTH ACETAMINOPHEN

    Acetaminophen 500 mg 

    Pain Reliever/Fever Reducer

    • 500 mg Acetaminophen in each tablet
    • Aspirin-free formula

    WORKPLACE READY®

    • Single Dose
    • Tamper Evident

    Xpect® First aid

    100 Tablets • 50 Packets per Box

    box-100

  • Principal Display Panel - 250 count Box

    Compare to the active ingredients in Extra Strength Tylenol®*

    MAXIMUM STRENGTH ACETAMINOPHEN

    Acetaminophen 500 mg

    Pain Reliever/Fever Reducer

    • 500 mg Acetaminophen in each tablet
    • Aspirin-free formula

    WORKPLACE READY®

    • Single Dose
    • Tamper Evident

    Xpect® First aid

    250 Tablets • 125 Packets per Box

    box-250

  • INGREDIENTS AND APPEARANCE
    XPECT ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-399
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-399-05250 in 1 BOX03/30/2021
    1NDC:42961-399-012 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    2NDC:42961-399-04100 in 1 BOX12/29/2022
    2NDC:42961-399-012 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/30/2021
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(42961-399)
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