Label: PHARBETOL REGULAR STRENGTH- acetaminophen tablet

  • NDC Code(s): 16103-353-07, 16103-353-08, 16103-353-11
  • Packager: Pharbest Pharmaceuticals, Inc.
  • 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 June 13, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient (in each tablet)

    Acetaminophen 325mg

  • 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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.

    Severe liver damage may occur if

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 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 in adults 
    • pain gets worse or lasts more than 5 days in children under 12 years
    • 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 the 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 tablets, every 4 to 6 hours while symptoms last
    • do not take more than 10 tablets in 24 hours, unless directe by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children 6 to under 12 years
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by a doctor
    children under 6 yearsask a doctor

  • Other information

    • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
    • store between 20-25°C (68-77°F)
  • Inactive ingredients

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

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-353-11

    Manufactured in the USA

    Regular Strength

    *COMPARE TO the active ingredients in TYLENOL® REGULAR STRENGTH TABLETS

    Contains no Aspirin

    PHARBETOL®

    Acetaminophen 325mg each

    Pain Reliever • Fever Reducer

    THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

    1000 TABETS

    Pharbetol 325 mg Tablet Package Label

  • INGREDIENTS AND APPEARANCE
    PHARBETOL  REGULAR STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-353
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code PH020
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-353-071 in 1 CARTON01/09/2007
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:16103-353-081 in 1 CARTON01/09/2007
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:16103-353-111000 in 1 BOTTLE; Type 0: Not a Combination Product01/09/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/09/2007
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835analysis(16103-353) , manufacture(16103-353) , pack(16103-353) , label(16103-353)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!