Label: CHILDRENS PAIN AND FEVER- acetaminophen 160mg/5ml solution

  • NDC Code(s): 73282-0011-1, 73282-0115-4
  • Packager: Calmco 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 January 11, 2022

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • Active Ingredient (in each 5mL)

    Acetaminophen, 160mg

    Purpose

    Pain reliever/fever reducer

  • Uses

    Temporarily: • reduces fever

    • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache

  • 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 for this product • 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

    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

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 use.

    • do not give more than directed (see overdose warning)

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

    • give the recommended number of vials below following the instructions under "Easy to Use" on the side panel.

    • empty each Single-Use Vial required of all liquid when dosing

    • if needed, repeat dose every 4 hours while symptoms last

    • do not give more than 5 times in 24 hours

    • do not give for more than 5 days unless directed by a doctor

    Dosing Chart

    Weight (lbs)Age (Years)Dose (mL)
    under 24 lbsunder 2 yearsTalk to a doctor
    24 -35 lbs2 - 3 years1 Single-Use Vial (5 mL)
    36 - 47 lbs4-5 yearsTalk to a doctor
    48 - 71 lbs6-10 years2 Single-Use Vial (10 mL)
    72 - 95 lbs11 years3 Single-Use Vial (15 mL)

  • Other information

    • each Single-Use vial contains 8mg of sodium
    • store at 68-77ºF (20-25ºC)
    • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
  • Inactive ingredients

    citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

  • Questions or Comments?

    +1 941-202-3270 or visit www.DrKids.com

  • Package

    Package

    Package

  • Package - 4ct

    Package 4ct

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen 160mg/5ml solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALTITOL (UNII: D65DG142WK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-0011-120 in 1 CARTON08/06/2021
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/06/2021
    CHILDRENS PAIN AND FEVER 
    acetaminophen 160mg/5ml solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALTITOL (UNII: D65DG142WK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-0115-44 in 1 CARTON01/11/2022
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/06/2021
    Labeler - Calmco LLC (079308308)