Otc - Active Ingredient
Active ingredients (in 15 mL)
Acetaminophen 325mg
Chlorpheniramine maleate 2mg
Dextromethorphan hydrobromide 10mg
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Stona For Children (NDC 49873-108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in 15 mL)
Acetaminophen 325mg
Chlorpheniramine maleate 2mg
Dextromethorphan hydrobromide 10mg
Purpose
Acetaminophen Pain reliever-fever reducer
Chlorpheniramine maleate Antihistamine
Dextromethorphan hydrobromide Cough suppressant
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
Do not use
Ask a doctor before use if the child has
Ask a doctor or pharmacist before use if the child is
When using this product
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.
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.
Directions
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 information
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.
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
* Please review the disclaimer below.