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  5. Label Information: Leader Infants Pain And Fever

FDA Label for Leader Infants Pain And Fever

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 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 YOUR 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. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Leader Infants Pain And Fever Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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



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 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, 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 has ever had an allergic reaction to this product or any of its ingredients

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



  • •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.



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 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
  • •mL = milliliter
  • •find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • •push air out of syringe. Insert syringe tip into bottle opening.
  • •flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
  • •pull yellow part of syringe until it reaches and stays at the correct dose
  • •dispense liquid slowly into child’s mouth, toward inner cheek
  • •repeat dose every 4 hours while symptoms last
  • •do not give more than 5 times in 24 hours
  • •replace cap tightly to maintain child resistance

    • Dosing Chart

    Weight (lb)

    Age (yr)

    Dose (mL)*

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL

    * or as directed by a doctor

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


Other Information



  • •store at 20-25°C (68-77°F)
  • •do not use if printed neckband is broken or missing

Inactive Ingredients



anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Infants’ Pain & Fever

Acetaminophen 160 mg per 5 mL

Oral Suspension

Pain Reliever

Fever Reducer

Grape Flavor

COMPARE TO INFANTS’ TYLENOL® ORAL SUSPENSION active ingredient

For Children

Alcohol-Free

Aspirin-Free

Ibuprofen-Free

100% Money Back Guarantee

2 FL OZ (59 mL)

USE ONLY WITH ENCLOSED SYRINGE.

SEE SIDE PANEL FOR MORE INFORMATION.

PEDIATRICIAN PREFERRED DOSING SYSTEM.


* Please review the disclaimer below.