Label: PHARBETOL- acetaminophen tablet

  • NDC Code(s): 16103-376-06, 16103-376-08, 16103-376-11
  • Packager: Pharbest Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 18, 2024

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  • Drug Facts

  • 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 4000 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
    • 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). Quick medical attention is critical for adults as well as for children even if you don't notice any signs or symptoms.

  • Directions

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

    adult and children 12 years and over
    • take 2 tablets, every 4 to 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 between 20-250C (68-770F)
  • 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 16103-376-11

    manufactured in the USA

    Extra Strength Contains no Aspirin

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

    PHARBETOL

    Acetaminophen 500mg

    Pain Reliever/ Fever Reducer

    THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

    1000 TABLETS

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Pharbetol 500 mg Tablet Package Label

  • INGREDIENTS AND APPEARANCE
    PHARBETOL 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-376
    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:16103-376-061 in 1 CARTON01/10/2006
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:16103-376-081 in 1 CARTON01/10/2006
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:16103-376-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/10/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01/10/2006
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835analysis(16103-376) , manufacture(16103-376) , pack(16103-376) , label(16103-376)
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