FDA Label for Infants Pain Reliever

View Indications, Usage & Precautions

Infants Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical Corporation. 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 1.6 Ml = 2 Droppersful)



Acetaminophen 160 mg


Purpose



Fever reducer/ pain reliever


Uses



temporarily:

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

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 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

Otc - Ask Doctor



Ask a doctor before use if your child has liver disease


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin


Otc - When Using



When using this product do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems


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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


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 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
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • fill to dose level. Do not use any other dosing device.
  • dispense liquid slowly into child's mouth, toward inner cheek.
  • if needed, repeat dose every 4 hours while symptoms last.
  • do not give use than 5 times in 24 hours
  • replace original bottle cap to maintain child resistance
  • use only with enclosed dropper
  • rinse dropper after each use
  • Dosing Chart

    Weight (lbs.)Age (yrs.)Dose ( mL)
    under 24under 2ask a doctor
    24-352-32 droppersful (0.8 + 0.8 mL)

    Attention: Specifically designed for use with enclosed dropper. Use only enclosed dropper to dose this product. Do not use any other dosing devices.


Other Information



  • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
  • •shake well before use.
  • •Store at room Temperature 15° - 30°C (59° - 86°F)
  • •protect from freezing.

Inactive Ingredients



butyl paraben, cellulose, citric acid, FD&C Blue # 1 FD&C Red # 33, glycerin, high fructose corn syrup, propylene glycol, sodium benzoate, sorbitol, water, xanthan gum


* Please review the disclaimer below.