FDA Label for Childrens Pain And Fever

View Indications, Usage & Precautions

Childrens Pain And Fever Product Label

The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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.

Drug Factsactive Ingredient(In Each 5 Ml = 1 Teaspoonful)



Acetaminophen 160 mg


Purpose



Pain reliever/fever reducer


Uses



temporarily

  • reduces fever
  • relieves 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 maxium daily amount
  • with other drugs containing acteaminophen
  • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

    • skin reddening
    • blisters
    • rash
    • If a skin reaction occurs, stopuse and seek medical help right away.

      Sore throat warning: If a sore throat is severe, persiss 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or to any of the inactive ingredients in this product

Ask A Doctor If Your Child Has



liver disease


Ask A Doctor Or Pharmacist Before Use If Your Child Is



taking the blood thinning drug warfarin.




(see overdose warnings)


Stop Use And Ask A Doctor If



  • pain gets worse or lasts 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.



Keep out of reach of children.


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 = millititer; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose, otherwise, use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give for more than 5 days unless directed by a doctor
  • Weight (lb)        Age (yr)            Dose (mL or Tsp)*
    under 24           under 2 years    ask a doctor

    24-35               2-3 years           5 mL (1 tsp)

    36-47               4-5 years           7.5 mL (1 1/2 tsp)

    48-59               6-8 years           10 mL (2 tsp)

    60-71               9-10 years          12.5 mL (2 1/2 tsp)

    72-95               11 years              15 mL

    * or as directed by a doctor

    Attention: use only enclosed dosing cup specfically designed for use with this product. Do not use any other dosing dvice


Other Information



  • eash 5mL (1 tsp) contains sodium 3mg
  • store between 20-25

Inactive Ingrediants



anhydrous citric acid, butylparaben, D&C Red # 33, FD&C (red), flavor, glycerin, flavor, high frucotose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum   


Questions



Call weekays from 9:30 AM to 4:30 PM


Children's Pain & Fever Product Label



DISCOUNT
drug mart
FOOD FAIR

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® ORAL SUSPENSION

Fever Reducer / Pain Reliever

Children's Pain & Fever

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Aspirin Free
  • For Ages 2 to 11

    GRAPE FLAVOR

    4 FL OZ (118 mL)
    160 mg per 5 mmL

    * This product is not manufactures or distributed by McNeil Consumer Healthcare, distribbutor of Children's Tylenol® Oral Suspension.

    BX-053

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256


* Please review the disclaimer below.