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  5. Label Information: Childrens Acetaminophen Oral Suspension Grape Flavor

FDA Label for Childrens Acetaminophen Oral Suspension Grape Flavor

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    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 YOUR CHILD
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN.
    11. OVERDOSE WARNING
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Childrens Acetaminophen Oral Suspension Grape Flavor 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.

Active Ingredient



(in each 5 mL)
Acetaminophen 160 mg


Purpose



Acetaminophen
160 mg.............................Pain reliever/fever reducer


Uses



temporarily

  • reduces fever
  • 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
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 non-prescription). 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



• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
These could be signs of a serious condition.


Keep Out Of Reach Of Children.



Enter section text here


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 or symptoms.


Directions



  • this product does not contain directions or complete warnings for adult use.
  • shake well before using
  • mL = mililiter
  • 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 (yr)        Dose (tsp or mL)
    under 24     under 2           ask a doctor
    24-35         2-3                    5 mL
    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 teaspoon (5mL) contains: sodium 3 mg
  • store between 15-30˚C (59-86˚F)
  • protect from freezing
  • protect from light

Inactive Ingredients



butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, D&C red # 33, FD&C blue # 1, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum


Questions Or Comments?



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


Principal Display Panel



Childrens Acetaminophen Oral Suspension

• Fever reducer
• Pain reliever

Alcohol Free
Aspirin Free
Ibuprofen Free

Grape Flavor

Compare to active ingredient in Childrens Tylenol Fever reducer Pain reliever

2 FL OZ (60 mL)


* Please review the disclaimer below.