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  5. Label Information: Better Living Brands Childrens Fever And Pain Reliver

FDA Label for Better Living Brands Childrens Fever And Pain Reliver

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (PER 5 ML)
    2. PURPOSE
    3. USES
    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 THE CHILD IS
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A 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

Better Living Brands Childrens Fever And Pain Reliver Product Label

The following document was submitted to the FDA by the labeler of this product Better Living Brands Llc. 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 (Per 5 Ml)



Acetaminophen 160 mg


Purpose



Pain reliever/fever reducer


Uses



Temporarily:

  • •reduces fever
  • •relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or 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, or 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 The 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



  • •new symptoms occur
  • •pain gets worse or lasts more than 3 days
  • •fever gets worse or lasts more than 5 days
  • •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) can cause serious liver damage. 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).
  • •Shake well before using
  • •Find right dose on chart below. (If possible, use weight to determine dosing; otherwise, use age.)
  • •Pour liquid into dosing cup to the appropriate amount for your child’s weight and/or age.
  • •Only use with enclosed dosing cup.
  • •If needed, repeat dose every 4 hours while symptoms last.
  • •Do not give more than 5 times in any 24-hour period (see overdose warning).
  • •Do not give more than 5 days unless directed by a doctor.
  • •Replace cap tightly to maintain child resistance.

    • Weight (lbs)

    Age (yrs)

    Dose

    under 24

    under 2

    Ask a doctor

    24-35

    2- under 4

    5 mL

    36-47

    4- under 6

    7.5 mL

    48-59

    6- under 9

    10 mL

    60-71

    9- under 11

    12.5 mL

    72-95

    11- under 12

    15 mL


Other Information



  • •Store at room temperature
  • •Check expiration date on bottle or box before using
  • •DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

Inactive Ingredients



citric acid, glycerin, natural flavor, potassium sorbate, povidone, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum


Questions Or Comments?



1-866-467-2748


Principal Display Panel



NDC 21130-746-04

Compare to the active ingredient in Little Remedies® Children’s Fever + Pain Reliever*

Children’s Fever + Pain Reliever

Acetaminophen 160 mg/ 5mL Pain reliever and Fever reducer

  • •Paraben Free
  • •Dye Free
  • •Gluten Free
  • •No Artificial Color
  • •No Aspirin or lbuprofen
  • •No High Fructose Corn Syrup

    • For Age 2-11

    Natural Grape Flavor

    4 FL. OZ. (118 mL)

    DISTRIBUTED BY:

    Lucerne North America LLC

    P.O. BOX 99, PLEASANTON, CA 94566-0009

    1-888-723-3929

    www.betterlivingbrandsLLC.com

    Keep this carton for future reference on full labeling.

    *This product is not manufactured or distributed by Prestige Consumer trademark Little Remedies® Children’s Fever + Pain Reliever.


* Please review the disclaimer below.