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Stona for Children

Dosage form: syrup
Ingredients: acetaminophen 325mg in 15mL, chlorpheniramine maleate 2mg in 15mL, dextromethorphan hydrobromide 10mg in 15mL
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-108

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

  • 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

​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

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.

Ask a doctor before use if the child has

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

Ask a doctor or pharmacist before use if the child is

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

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

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

  • 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 information

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

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

STONA FOR CHILDREN 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-108
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen325 mg  in 15 mL
chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate2 mg  in 15 mL
dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide10 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
BUTYLPARABEN 
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SUCROSE 
WATER 
POLYETHYLENE GLYCOL 1500 
Product Characteristics
Color    Score    
ShapeSize
FlavorBANANA (banana) , EGG NOG (sweet yogurt) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49873-108-011 BOTTLE in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/03/2001
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-108), label(49873-108), pack(49873-108)

Revised: 03/2017
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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