Label: PHARBETOL- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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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 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
    •
    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.

    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).

    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

    •
    Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
    •
    store between 20-250C (68-770F)
  • Inactive ingredients

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

  • Questions?

    Adverse drug event call: 1-866-562-2756 Mon - Fri: 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    Repackaged By:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    NDC 71205-478-50

    manufactured in the USA

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

    Do not use with any other product containing acetaminophen

    PHARBETOL

    Acetaminophen 500mg

    Pain Reliever • Fever Reducer

    50 TABLETS

    71205-478-50
  • INGREDIENTS AND APPEARANCE
    PHARBETOL 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-478(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:71205-478-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2024
    2NDC:71205-478-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2020
    3NDC:71205-478-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2020
    4NDC:71205-478-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/12/2020
    5NDC:71205-478-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/12/2020
    6NDC:71205-478-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2020
    7NDC:71205-478-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/10/2006
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-478) , RELABEL(71205-478)
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