Label: ARAMARK EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet

  • 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 July 19, 2021

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient (in each tablet)
    Acetaminophen 500 mg

  • PURPOSE

    Purpose
    Acetaminophen ...................Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Uses:
    Temporarily Relieves minor aches and pains
    due to:
    • Headache, toothaches, menstrual cramps,
      the common cold,
    • muscular aches, minor pain of arthritis
      Temporarily reduces fever

  • WARNINGS

    Warnings:
    Allergy Alert: Acetaminophen may cause a severe skin
    reactions.
    Symptoms may include:
    • Skin reddening •Blisters •Rash
    • If a skin reaction occurs, stop use and seek medical
      right away.

    Liver Warning: This product contains an
    acetaminophen. Severe liver damage may occur if you
    take:
    • more than 8 tablets in 24 hours, which is the
    maximum daily amount
    • 3 or more alcoholic drinks every day while using this
    product

    • take more or for a longer time than directed

  • DO NOT USE

    Do not use:
    • if you have ever had an allergic reaction to any
      other pain
    • reliever/fever reducer
    • right before or after heart surgery
    • if you have ever had an allergic reaction to this
      product or any of its ingredients

  • 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:
    • under a doctor’s care for any serious condition
    • taking the blood thinning drug Warfarin

  • WHEN USING

    When using this product:
    • take with food or milk if stomach upset occurs
    • the risk of heart attack or stroke may increase if
      you use more than directed or for longer than
      directed

  • STOP USE

    Stop use and ask a doctor if:
    • pain gets worse lasts more than 10 days
    • feel faint
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms occur

  • 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. In case of 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.

  • DOSAGE & ADMINISTRATION

    Directions:
    do not take more than directed
    • adults and children 12 years and over: take 2
      tablets every 4 to 6 hours as needed
    • do not exceed 8 tablets in 24 hours, unless
      directed by a doctor
    • Children under 12 years: Do not use this product

  • OTHER SAFETY INFORMATION

    Other information:
    read all warnings and directions before use. Keep
    carton. Store at 20-25°C (68-77°F) avoid excessive
    heat above 40°C (104°F)

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Microcrystalline Cellulose, Povidone, Sodium Starch
    Glycolate, Starch, Stearic Acid

  • Package Labeling

    aramark

    100 TABLETS        Part # 90433B
    PER BOX

    Extra Strength
    Acetaminophen
    Pain Reliever/Fever Reducer

    Temporary relief of minor aches and
    pains associated with a cold,
    headache, tootache, muscular aches,
    and for the reduction of fever

    Compare active ingredient to:
    Extra Strength Tylenol®
    Registered Trademark of Johnson & Johnson

    MANUFACTURED FOR:

    Aramark
    Lenexa, KS 66219
    866-362-2691

    aramarkuniform.com

    Retain carton for complete product information

    100 Tablet Box

    100 ct 3500-1 Box

    250 Tablet Box

    250 ct 3500-2 Box

    2-Tablet Packet

    2ct 3500 Packet

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK EXTRA STRENGTH ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-3500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize18mm
    FlavorImprint Code FR1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-3500-150 in 1 BOX05/14/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:81238-3500-2125 in 1 BOX05/14/2021
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/14/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(81238-3500)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION944090448manufacture(81238-3500)