Label: CHILDRENS PAIN RELIEF- acetaminophen 80 mg 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 March 3, 2015

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  • Active ingredient

    Acetaminophen 80 mg

  • Purpose

    Analgesic/Antipyretic

  • Uses

    temporary relief of minor aches and pains associated with common cold and flu headache toothache sore throat immunizations and reduction of fever

  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

    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

    Ask doctor before use if your child has

    liver disease

    Ask doctor or pharmacist before use if

    the user is taking the blood thinning drug warfarin

    When using this product

    do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems

    Stop use and ask a doctor if

    symptoms do not improve pain gets worse or lasts more than 5 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present You may report side effects to 888-952-0050

  • Keep Out of Reach of Children

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms

  • Directions

    this product does not contain directions or complete warnings for adult usechew tablets before swallowing all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period follow the chart below for proper dosing or as directed by a doctor if possible, use weight for dosing, otherwise use age

    Weight (lbs)

    Under 24

    24-35

    36-47

    48-59

    60-71

    72-95

    Age (yrs)

    Under 2

    2-3

    4-5

    6-8

    9-10

    11

    Tablets

    Consult a doctor

    2

    3

    4

    5

    6
  • Other information

    Phenylketonurics: contains phenylalanine 2.8 mg per tablet store at room temperature protect from excessive moisture do not use if imprinted safety seal under cap is broken or missing

  • Inactive Ingredients

    aspartame, croscarmellose sodium, D&C red #7, flavors, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose

  • Package/Label Principal Display Panel

    Z:\SPL-OTC Mono\Allegiant Health\Children's Pain Relief\LB0170.jpg
  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF 
    acetaminophen 80 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize10mm
    FlavorFRUITImprint Code AZ023
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-023-3030 in 1 BOX; Type 0: Not a Combination Product03/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/03/2015
    Labeler - Allegiant Health (079501930)
    Registrant - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930LABEL(69168-023) , MANUFACTURE(69168-023) , PACK(69168-023) , RELABEL(69168-023) , REPACK(69168-023)
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