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  ■pains  ■headache  ■sneezing  ■muscular aches  ■fever
■runny nose  ■cough due to minor throat and bronchial irritation

Warnings


Do not give this product unless directed by a doctor
■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

Ask a doctor or pharmacist before use if the child is
■taking sedatives or tranquilizers

When using this product
■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.

A persistent cough may be a sign of a serious condition. If cough persists for more than 7 days, tends to recur, or is accompanied by rash, persistent headache, or fever that lasts more than 3 days, consult a doctor.

Keep our of reach of children.  In case of accidental 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, not to exceed 75 mL in 24 hours, or as directed by a doctor.
■Children under 6 years: Ask a doctor.

Inactive ingredients
alcohol, butylparaben, citric acid, FD and C Red No. 40, flavor, PEG-32, propylparaben, propylene glycol, sodium benzoate, sodium hydroxide, sodium saccharin, sugar, water.

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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 DIHYDRATE 
SUCROSE 
WATER 
POLYETHYLENE GLYCOL 1500 
Product Characteristics
Color    Score    
ShapeSize
FlavorBANANA, EGG NOG (sweet yogurt) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49873-108-011 BOTTLE (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, label, pack

Revised: 01/2012
 
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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