STONA FOR CHILDREN- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide syrup

Stona for Children by

Drug Labeling and Warnings

Stona for Children by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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.

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.

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STONA FOR CHILDREN 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-108
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)	acetaminophen	325 mg  in 15 mL
chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (chlorpheniramine - UNII:3U6IO1965U)	chlorpheniramine maleate	2 mg  in 15 mL
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS)	dextromethorphan hydrobromide	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)

Product Characteristics
Color		Score
Shape		Size
Flavor	BANANA (banana) , EGG NOG (sweet yogurt)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-108-01	1 in 1 CARTON	01/03/2001
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/03/2001

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-108) , label(49873-108) , pack(49873-108)