Label: DRKIDS CHILDRENS PAIN AND FEVER- acetaminophen 80mg/piece bar, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2024

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  • Drug Facts

  • Active ingredient and Purpose

    Active Ingredient (in each piece)Purpose
    Acetaminophen 80mg ..........................Pain reliever/ fever reducer

  • Uses

    Temporarily relieves minor aches and pains due to:

    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
    • temporarily reduces fever
  • Warnings

    Liver warning:this product contains acetaminophen. Severe liver damage may occur if your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    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

    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.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if your child has

    liver disease

    Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dose (see overdose warning)

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 5 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.

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-12220 Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Other Information

    • each piece contains: sodium 6 mg. low sodium
    • store in a cool dry place between 20-25°C (68-77°F).
    • Child Resistant Container; do not use if printed seal under cap is broken or missing.
  • Inactive Ingredients

    ammonium glycyrrhizate, flavors, geleol mono and diglycerides, glucode syrup, maltitol solution, maltodextrin, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

  • Questions or comments?

    Call 1-941-202-3270

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see overdose warning)
    • find right dose on the chart below. If possible, use weight to dose; otherwise, use age
    • chocking hazard: instruct child to chew each piece thoroughly before swallowing
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours

    Dosing Chart

    Weight (lbs)

    		Age (Years)Dose (per piece)*
    under 24under 2 yearsask a doctor
    24-352-32
    36-474-53
    48-596-84
    60-719-105
    72-95116

    *or as directed by a doctor

  • Principal Display Panel

    label PDPlabel continued

  • INGREDIENTS AND APPEARANCE
    DRKIDS CHILDRENS PAIN AND FEVER 
    acetaminophen 80mg/piece bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-2480
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    MALTITOL (UNII: D65DG142WK)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    NEOTAME (UNII: VJ597D52EX)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SUCROSE (UNII: C151H8M554)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Colorwhite (opaque, beige) Scorescore with uneven pieces
    ShapeRECTANGLESize15mm
    FlavorORANGE (Orange Vanilla Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-2480-124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/01/2023
    Labeler - CalmCo LLC (079308308)
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