Label: ACETAMINOPHEN- acetaminophen 325mg tablet

  • NDC Code(s): 72615-0001-0
  • Packager: America's Pharmacy Source LLC
  • 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 November 13, 2019

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  • 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 prduct 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 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount
    • 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 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 directed by a doctor
      • do not take for more than 10 days unless directed by a doctor
      children 6 to 11 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

    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    povidone, pregelatinized 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

    COMPARE TO ACTIVE

    INGREDIENT IN

    TYLENOL ® REGULAR STRENGTH

    AMERICA'S

    PHARMACY SOURCE

    REGULAR STRENGTH

    Acetaminophen

    Pharbetol l Pain Reliever l Fever Reducer

    NDC# 72615-0001-0

    100 TABLETS - 325mg Each

    www.AmericasPharmacySource.com

    APS Acetaminophen 325mg

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen 325mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72615-0001
    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:72615-0001-0100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/02/2019
    Labeler - America's Pharmacy Source LLC (116701866)
    Registrant - America's Pharmacy Source LLC (116701866)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(72615-0001) , analysis(72615-0001) , repack(72615-0001) , relabel(72615-0001)
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