Label: PHARBETOL- acetaminophen 500mg tablet, coated

  • 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 1, 2018

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  • Active ingredient (in each caplet)

    Acetaminophen 500mg

  • 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 caplets 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
    • 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 the 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 caplets, every 6 hours while symptoms last
      • do not take more than 6 caplets in 24 hours, unless directed by a doctor
      • do not take 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 20o-25oC (68o-77oF)
  • Inactive ingredients

    hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-350-11

    Manufactured in the USA

    Extra Strength *COMPARE TO the active ingredient in EXTRA STRENGTH TYLENOL® CAPLETS

    Do not use with any other product containing acetaminophen

    PHARBETOL

    Acetaminophen 500 mg

    Pain Reliever • Fever Reducer

    1000 CAPLETS

    Pharbetol 500 mg Caplet Product Label Image

  • INGREDIENTS AND APPEARANCE
    PHARBETOL 
    acetaminophen 500mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-350
    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)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Capsule Shaped Tablet (Caplet)) Size18mm
    FlavorImprint Code PH016
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-350-041 in 1 CARTON03/01/2018
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:16103-350-081 in 1 CARTON03/01/2018
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:16103-350-10500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    4NDC:16103-350-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/01/2018
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-350) , label(16103-350) , pack(16103-350)
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