Label: CRANE SAFETY XS NON-ASPIRIN- acetaminophen 500 mg tablet, film coated

  • NDC Code(s): 73408-127-33, 73408-904-33
  • Packager: Crane Safety LLC
  • 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 31, 2023

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

  • Drug Facts

  • Active ingredient

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    For the temporary relief of minor aches and pains associated with

    • headache
    • toothache
    • minor arthritis pain
    • muscular aches
    • common cold
    • menstrual cramps

    For the reduction of fever.

  • Warnings

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

    • more than 8 tablets 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

    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.

    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
  • 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 using and ask a doctor if

    • symptoms do not improve
    • pain or fever persists or gets worse
    • new symptoms occur
    • redness or swelling is present
  • 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 use more than directed

    Adults and children: (12 years and older)

    Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

    Children under 12 years:

    Do not give this adult strength product to children under 12 years of age;

    this will provide more than the recommended dose (overdose) and may cause liver damage.

  • Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • Inactive ingredients

    corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

    * may contain

  • Questions or comments?

    877.506.4291

  • Crane Safety XS Non-Aspirn Label

    Extra Strength

    Non-Aspirin

    Pain Reliever/Fever Reducer

    CRANE Safety®

    Pull To Open

    This Package Is For Households without Young Children.

    Aches, Fever

    Acetaminophen 500 MG

    100 Tablets

    Tamper Evident

    Sealed Packets

    C1 XS

  • Crane Safety XS Non-Aspirin

    Extra Strength

    Non-Aspirin

    Pain Reliever/Fever Reducer

    CRANE Safety®

    Pull To Open

    This Package Is For Households without Young Children.

    Aches, Fever

    Acetaminophen 500 MG

    100 Tablets

    Tamper Evident

    Sealed Packets

    C2 XS

  • INGREDIENTS AND APPEARANCE
    CRANE SAFETY XS NON-ASPIRIN 
    acetaminophen 500 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-904
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-904-3350 in 1 BOX01/17/2020
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/17/2020
    CRANE SAFETY XS NON-ASPIRIN 
    acetaminophen 500 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-127-3350 in 1 BOX01/17/202006/01/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/17/202006/01/2023
    Labeler - Crane Safety LLC (080998015)
    Registrant - Unifirst First Aid Corporation (832947092)