Label: HENRY SCHEIN ACETAMINOPHEN- acetaminophen tablet, film coated

  • NDC Code(s): 0404-0714-13, 0404-0714-99
  • Packager: Henry Schein, 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 May 13, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • minor pain of arthritis
    • backaghe
    • the common cold
    • toothache
    • premenstral and menstrual cramps

    temporarily reduces fever

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg 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

    Stop use and ask a doctor if

    • pain gets worse or lasts for 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    ​

    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
    • do not use for more than 10 days unless directed by a doctor

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature 59°-86°F (15°-30°C)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

    Questions or comments? 1-800-472-4346

  • PRINCIPAL DISPLAY PANEL

    Henry Schein®

    Acetaminophen

    For the temporary relief of minor aches and pains
    associated with the headache, muscular aches, minor arthritis pain,
    common cold, toothache, menstrual cramps and for the reduction of fever.

    Henry Schein Seal of Excellence®

    Pull to Open

    This Package is for Households without Young Children.

    Reorder

    900-4689

    Acetaminophen 325 mg

    250 Packets/2 Tablets

    Henry

  • INGREDIENTS AND APPEARANCE
    HENRY SCHEIN ACETAMINOPHEN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0714
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code AZ;234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0714-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    2NDC:0404-0714-13250 in 1 BOX12/30/2008
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/30/2008
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Unifirst First Aid Corporation (832947092)
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