Label: PHARBETOL- 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 February 4, 2023

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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

  • HOW SUPPLIED

    Product: 50090-0395

    NDC: 50090-0395-0 15 TABLET in a BOTTLE

    NDC: 50090-0395-1 30 TABLET in a BOTTLE

    NDC: 50090-0395-2 100 TABLET in a BOTTLE

    NDC: 50090-0395-3 50 TABLET in a BOTTLE

    NDC: 50090-0395-4 24 TABLET in a BOTTLE

    NDC: 50090-0395-5 20 TABLET in a BOTTLE

    NDC: 50090-0395-8 2 TABLET in a BOTTLE

  • Acetaminophen

    Label Image
  • INGREDIENTS AND APPEARANCE
    PHARBETOL 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0395(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:50090-0395-82 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2017
    2NDC:50090-0395-2100 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    3NDC:50090-0395-520 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    4NDC:50090-0395-015 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    5NDC:50090-0395-350 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    6NDC:50090-0395-424 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    7NDC:50090-0395-130 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/10/2006
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0395) , REPACK(50090-0395)
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