FDA Label for Childrens Acetaminophen

View Indications, Usage & Precautions

Childrens Acetaminophen 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 5 Ml = 1 Teaspoon)



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
    • 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 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

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 (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.


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.
  • if needed, repeat dose every 4 hours
  • do not use more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • only use enclosed measuring cup
  • Weight (lbs.)Age (yrs.)Dose (tsp or mL)
    under 24under 2ask a doctor
    24-352-31 tsp or 5 mL
    36-474-51½ tsp or 7.5 mL
    48-596-82 tsp or 10 mL
    60-719-102½ tsp or 12.5 mL
    72-95113 tsp or 15 mL

Other Information



  • •Store at room temperature 15° - 30°C (59° - 86°F)
  • •Protect from Freezing.
  • •Protect from Light.
  • •each teaspoon (5 mL) contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive Ingredients



butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red # 40, flavor, glycerin, propylene glycol, water, sodium benzoate, sorbitol, xanthan gum, Sodium saccharin.


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