Stona For Children
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide
Sato Pharmaceutical Co., Ltd.
Human Otc Drug
NDC 49873-108Stona For Children also known as Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide is a human otc drug labeled by 'Sato Pharmaceutical Co., Ltd.'. National Drug Code (NDC) number for Stona For Children is 49873-108. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Stona For Children drug includes Acetaminophen - 325 mg/15mL Chlorpheniramine Maleate - 2 mg/15mL Dextromethorphan Hydrobromide - 10 mg/15mL . The currest status of Stona For Children drug is Active.
Drug Information:
| Drug NDC: | 49873-108 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Stona For Children |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sato Pharmaceutical Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Syrup |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 325 mg/15mL
CHLORPHENIRAMINE MALEATE - 2 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/15mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 03 Jan, 2001 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Sato Pharmaceutical Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1236070
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0349873058016
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
V1Q0O9OJ9Z
9D2RTI9KYH
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 49873-108-01 | 1 BOTTLE in 1 CARTON (49873-108-01) / 120 mL in 1 BOTTLE | 03 Jan, 2001 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose acetaminophen pain reliever-fever reducer chlorpheniramine maleate antihistamine dextromethorphan hydrobromide cough suppressant
Product Elements:
Stona for children acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide alcohol butylparaben citric acid monohydrate fd&c red no. 40 propylparaben propylene glycol sodium benzoate sodium hydroxide saccharin sodium sucrose water polyethylene glycol 1500 acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan banana sweet yogurt
Indications and 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:
âwarnings âliver warning: â 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 parkinsonâs disease), or for 2 weeks after stopping the maoi drug. if you do not know if your childâs 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
Read more... 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 â pain or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â 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.
Do Not Use:
âwarnings âliver warning: â 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 parkinsonâs disease), or for 2 weeks after stopping the maoi drug. if you do not know if your childâs 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 â pain or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â 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.
When Using:
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 and 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. âthis product does not contain directions or complete warnings for adult use
Stop Use:
Stop use and ask a doctor if â pain or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Carton image carton image
Further Questions:
âquestions or comments? â â 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