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  5. Label Information: Family Wellness Childrens Pain Reliever 574

FDA Label for Family Wellness Childrens Pain Reliever 574

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Family Wellness Childrens Pain Reliever 574 Product Label

The following document was submitted to the FDA by the labeler of this product Family Dollar Services, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 20-25°C (68-77°F)


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


* Please review the disclaimer below.