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


Keep Out Of Reach Of Children.



Keep out of reach of children.


Uses



temporarily

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

Warnings



DO NOT USE IF PRINTED NECK BRAND IS BROKEN OR MISSING

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 acetaminophen
  • Sore throat warning

    If sore throat is severe, persists for more than two 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 any of the inactive ingredients in this product.

Asl 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.




  • pain gets worseor 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.


Overdose Warning



Taking more than the recommended dose (overdose) may can liver damage. . In case of overdose, get medical help, or contact a Poison Control Center right away.(1-800-22212120.) Quick medical attention is critical for adults as well as 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 = milliter; tsp = teaspoon
  • 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 more than 5 times in 24 hours
  • 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 (3 tsp)

    * or as directed by a doctor

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


Other Information



  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20°-25°C (68°-77°F)
  • do not refrigerate

Inactive Ingredients



anhydrous citric acid, butylparaben, FD and C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum


Questions?



Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944


Discount Drug Mart Food Fair Children's Pain And Fever Product Label



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

DISCOUNT

drug mart

FOOD FAIR

Fever Reducer/ Pain Reliever

Children's Pain and Fever

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Asprin Free
  • For ages 2 to 11

    CHERRY FLAVOR

    4 FL  OZ (118  mL)

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

    BX-043

    SATISFACTION GUARANTEED

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


* Please review the disclaimer below.