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

  • 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 29, 2023

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  • Active ingredient (in each piece)

    Acetaminophen 80 mg

  • Purpose

    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.

    Keep Out of Reach Of Children

    Keep out of reach of children.

    When using this product do not exceed recommended dose (see overdose warning)

    Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

    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.

    Ask a doctor before use if your child has liver disease

    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.

  • 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 chart below. If possible, use weight to dose; otherwise, use age
    • 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

    Weight (lb)Age (yr)Dose (piece)*
    Under 24Under 2 yearsAsk a doctor
    24-352-3 years2 pieces
    36-474-5 years3 pieces
    48-596-8 years4 pieces
    60-719-10 years5 piceces
    72-9511 years6 pieces

    *or as directed by a doctor

  • 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

  • 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 not finalpart34307/01/2023
    Labeler - CalmCo LLC (079308308)
    Registrant - CalmCo LLC (079308308)
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