Label: ADWE CHILDRENS PAIN FEVER- acetaminophen suspension

  • NDC Code(s): 68163-695-04
  • Packager: RARITAN PHARMACEUTICALS 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 August 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • 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
    ▪
    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. (1-800-222-1222) 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)
    •
    shake well before using
    •
    mL = milliliter
    •
    find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    •
    remove the child protective cap and squeeze your child's dose into the dosing cup
    •
    repeat dose every 4 hours while symptoms last
    •
    do not give more than 5 times in 24 hours
    Weight (lb)Age (yr)Dose (mL) **

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL

    36-47

    4-5 years

    7.5 mL

    48-59

    6-8 years

    10 mL

    60-71

    9-10 years

    12.5 mL

    72-95

    11 years

    15 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    ▪
    very low sodium
    ▪
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    NDC 68163-695-04

    Adwe

    Feverx

    Children’s Pain+Fever Relief

    Acetaminophen
    Oral Suspension


    PAIN RELIEVER-FEVER REDUCER

    Compare to the active ingredient in Children’s Tylenol® Dye-Free Oral Suspension*

    For Ages 2-11 Years

    •
    Dye-Free
    •
    No Added Alcohol
    •
    Sugar Free

    4 FL. OZ. (120 mL)
    160 mg per 5 mL

    CHERRY FLAVOR
    Naturally Flavored

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributer of Children’s Tylenol® Dye-Free Oral Suspension.

    Manufactured for : Adwe Laboratories

    1274 49 Street Brooklyn, NY 11219

    ADWE Children's Pain+ Fever Relief Acetaminophen Oral Suspension
  • INGREDIENTS AND APPEARANCE
    ADWE CHILDRENS PAIN FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-695
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-695-041 in 1 PACKAGE01/17/2022
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/17/2022
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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