Label: PHARBETOL- acetaminophen 500mg tablet

  • NDC Code(s): 73057-376-08, 73057-376-11
  • Packager: Ulai Health 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 January 31, 2022

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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:
    • the common cold
    • headache
    • 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 a 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
    • redness or swelling is present
    • new symptoms occur

    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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • do not take more than directed (see overdose warning)

    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 use for more than 10 days unless directed by a doctor

    children under 12 years

    ask a doctor

  • Other information

    • store at 20-25 0C (68-77 0F)
  • Inactive ingredients

    povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

  • Questions or comments?

    (866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 73057-376-11

    Manufactured in the USA

    Extra Strength *Compare to the active ingredient in Extra Strength Tylenol ® Caplet

    Contains no Aspirin

    PHARBETOL

    Acetaminophen 500 mg each

    Pain Reliever/Fever Reducer

    1000 TABLETS

    Ulai Pharbetol 500 mg Tablet 1000 ct. Label

  • INGREDIENTS AND APPEARANCE
    PHARBETOL 
    acetaminophen 500mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-376
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code PH044
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-376-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
    2NDC:73057-376-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/08/2019
    Labeler - Ulai Health LLC (081181535)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(73057-376) , analysis(73057-376) , label(73057-376) , pack(73057-376)
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