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  5. Label Information: Stona For Children

FDA Label for Stona For Children

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. OTHER SAFETY INFORMATION
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stona For Children Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. 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.

Otc - Active Ingredient



Active ingredients (in 15 mL)
Acetaminophen 325mg
Chlorpheniramine maleate 2mg
Dextromethorphan hydrobromide 10mg


Otc - Purpose



Purpose
Acetaminophen    Pain reliever-fever reducer
Chlorpheniramine maleate    Antihistamine
Dextromethorphan hydrobromide    Cough suppressant


Indications & Usage



Uses

  • For the temporary relief of the following cold symptoms 
  • minor aches and pains
  • headache
  • sneezing
  • runny nose
  • cough due to minor throat and bronchial irritation
    • temporarily reduces fever

Warnings



​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 for this product
  • with other drugs containing acetaminophen

Otc - Do Not Use



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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Otc - Ask Doctor



Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • liver disease

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if the child is

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Otc - When Using



When using this product

  • do not exceed recommended dosage
  • may cause excitability in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect

Otc - Stop Use



Stop use and ask a doctor if
■pain or cough gets worse or lasts more than 5 days
■fever gets worse or lasts more than 3 days
■redness or swelling is present
■new symptoms occur
■cough comes back or occurs with rash or headache that lasts.
  These could be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.


Dosage & Administration



Directions

  • do not take more than 5 doses in any 24 hour period
  • use only with enclosed measuring cup
  • dose as follows while symptoms persist, or as directed by a doctor

    •       children 6 to under 12 years of age: Take 15 mL every 4 hours

          children under 6 years of age: do not use. ask a doctor.

    ​This product does not contain directions or complete warnings for adult use


Other Safety Information



​Other information

  • ​​keep container tightly closed
  • store at room temperature (20​​-25 C or 68-77 F)

Inactive Ingredient



Inactive ingredients
alcohol, butylparaben, citric acid, FD&C Red No. 40, flavor, polyethylene glycol 1540, propylparaben, propylene glycol, saccharin sodium, sodium benzoate, sodium hydroxide, sucrose, water.


Otc - Questions



​Questions or comments?​​

or to report serious adverse events associated with the use of this product call weekdays, 9 am - 5 pm at 1-310-787-1877 or write to the address on the front panel


Package Label.Principal Display Panel



PDP - StSyrChildv2 PDP

PDP - StSyrChildv2 PDP


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