Label: STONA FOR CHILDREN- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide syrup
- NDC Code(s): 49873-108-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
-
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
- INACTIVE INGREDIENT
- QUESTIONS
- Carton Image
-
INGREDIENTS AND APPEARANCE
STONA FOR CHILDREN
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide syrupProduct 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 BUTYLPARABEN (UNII: 3QPI1U3FV8) ALCOHOL (UNII: 3K9958V90M) 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 Drug M012 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)
