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  5. Label Information: Childrens Acetaminophen Liquid

FDA Label for Childrens Acetaminophen Liquid

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - 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 A DOCTOR IF
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OVERDOSAGE
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS & COMMENTS
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Childrens Acetaminophen Liquid Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributor 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.

Otc - Active Ingredient



Active Ingredient: Acetaminophen 160 mg (in each 5 mL)


Otc - Purpose



Purpose: Pain reliever/fever reducer


Indications & Usage



Uses

temporarily:

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

Warnings



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

    • 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.


Otc - Do Not Use



Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). if you are not sure wheather 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 or warfarin


When Using This Product



do not exceed recommended dose (see overdose warning)


Stop Use And Ask A Doctor If



  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 5 days
  • fever gets worse or lasts for more than 3 days

    • These could be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdosage



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 for adults as well as for children even if you do not notice any signs of symptoms.


Directions



  • this product does not contain directions or complete warnings for adult use.
  • Shake well before using
  • mL = mililliter
  • find right dose on chart below. if possible, use weight to dose; otherwise use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor.

    • Weight (lb.)        Age (yrs.)      Dose (mL)*

    Under 24             Under 2         Ask a doctor

    24-35                    2-3                 5mL

    36-47                    4-5                 7.5 mL

    48-59                    6-8                 10 mL

    60-71                    9-10               12.5 mL

    72-95                    11                  15 mL

    * always check with your doctor before administering medicine to your infant child


Other Information



  • each 5 mL contains: sodium 7 mg
  • store between 15°-30°C (59°-86°F)
  • protect from freezing
  • protect from light

Inactive Ingredients



citric acid, FD&C red no. 40, flavor, glycerin, PEG 400, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol


Questions & Comments



1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Package Label.Principal Display Panel



Compare to the active ingredient in Children's Tylenol®*
Children's Acetaminophen Elixir
Cherry Flavor
For ages 2 to 11
2 FL OZ (60 mL)

This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®.


* Please review the disclaimer below.