Label: FAMILY WELLNESS CHILDRENS PAIN RELIEVER 574- acetaminophen suspension

  • NDC Code(s): 55319-930-03
  • Packager: Family Dollar Services, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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

View All Sections
  • ACTIVE INGREDIENT(S)

    Acetaminophen 160mg

  • PURPOSE

    Pain reliever/fever reducer

  • USE(S)

    temporarily: 

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

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


  • DO NOT USE

    • with any other product containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
    • 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 DOCTOR IF

    • pain gets worse or last 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.


  • DIRECTIONS

    • do not give more than directed (see overdose warning)
    • shake well before use
    • this product does not contain directions or complete warning for adult dose
    • use only with enclosed dosing cup
    • repeat dose every 4 hours while symptoms last
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • mL = milliliter

    Weight (lb) Age (yr) Dose (mL) 
      under 24 lbs under 2 years ask a doctor
     24-35 lbs 2-3 years 5 mL
     36-47 lbs 4-5 years 7.5 mL
     48-59 lbs 6-8 years 10 mL
     60-71 lbs 9-10 years 12.5 mL
     72-95 lbs 11 years 15 mL

  • OTHER INFORMATION

    store between 20-25ºC (68-77ºF)

  • INACTIVE INGREDIENTS

    butylparaben, citric acid, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sucralose, Xanthan gum.

  • QUESTIONS OR COMMENTS?

    Call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

  • PRINCIPAL DISPLAY PANEL

    FAMILY WellnessTM

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDRENS TYLENOL® LIQUID*


    children's PAIN RELIEVEER

    AGE 2 - 11 YEARS

    ACETAMINOPHEN 160 mg per 5 mL

    Oral Suspension Liquid

    PAIN RELIEVER/FEVER REDUCER


    • Alcohol Free
    • Aspirin Free
    • Ibuprofen Free

    DYE-FREE

     CHERRY FLAVOR

    4 FL OZ (118 mL)

    574-label-fw

     

    574-carton-fw
  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS CHILDRENS PAIN RELIEVER 574 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-930
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-930-031 in 1 CARTON04/18/2024
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGpart34304/18/2024
    Labeler - Family Dollar Services, Inc. (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(55319-930)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!