2. Drugs
  3. Human OTC Drug
  4. Stonarhini

Stonarhini

Chlorpheniramine Maleate, Phenylephrine


Sato Pharmaceutical Co., Ltd.
Human Otc Drug
NDC 49873-109
Stonarhini also known as Chlorpheniramine Maleate, Phenylephrine is a human otc drug labeled by 'Sato Pharmaceutical Co., Ltd.'. National Drug Code (NDC) number for Stonarhini is 49873-109. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Stonarhini drug includes Chlorpheniramine Maleate - 2 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Stonarhini drug is Active.

Drug Information:

Drug NDC: 49873-109
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: Stonarhini
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: Chlorpheniramine Maleate, Phenylephrine
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: Tablet
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:CHLORPHENIRAMINE MALEATE - 2 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/1
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: 16 Nov, 2001
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 Jun, 2026
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:1242240
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:0349873033037
UPC stands for Universal Product Code.
UNII:V1Q0O9OJ9Z
04JA59TNSJ
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:Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-1 Adrenergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
49873-109-014 BLISTER PACK in 1 CARTON (49873-109-01) / 6 TABLET in 1 BLISTER PACK16 Nov, 2001N/ANo
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.
Other medicines with the same generic name

Stonarhini


Chlorpheniramine Maleate, Phenylephrine

Tablet
Sato Pharmaceutical Co., Ltd.
NDC: 49873-109

Purpose:

Purpose chlorpheniramine maleate antihistamine phenylephrine hcl nasal decongestant

Product Elements:

Stonarhini chlorpheniramine maleate, phenylephrine aspartame silicon dioxide fd&c red no. 40 hydroxypropyl cellulose (type el) magnesium stearate mannitol aluminum oxide chlorpheniramine maleate chlorpheniramine phenylephrine hydrochloride phenylephrine pale red s10

Indications and Usage:

Uses temporarily relieves these symptoms due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis). ■ sneezing ■ runny nose ■ itchy, watery eyes ■ nasal congestion, stuffy nose ■ itchy throat

Warnings:

Warnings ​ enter section text here do not use this product ■ if you are 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 prescription contains an maoi, ask a doctor or pharmacist before taking this priduct. ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ heart disease ■ thyroid disease ■ diabetes ■ high blood pressure ■difficulty in urination due to enlargement of the prostate ask a doctor or pharmacist before use ■ if you are taking sedatives or tranquilizers when using this product ■ do not exceed recommended dosage. if nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. ■ you may get drowsy. ■ may cause excitability, especially in children. â–
alcohol, sedatives and tranquilizers may increase the drowsiness effect. ■ avoid alcoholic beverages. ■ use caution when driving a motor vehicle or operating machinery. stop use and ask a doctor if ■ symptoms do not improve within seven days ■ symptoms are accompanied by fever

Do Not Use:

Warnings ​ enter section text here do not use this product ■ if you are 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 prescription contains an maoi, ask a doctor or pharmacist before taking this priduct. ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ heart disease ■ thyroid disease ■ diabetes ■ high blood pressure ■difficulty in urination due to enlargement of the prostate ask a doctor or pharmacist before use ■ if you are taking sedatives or tranquilizers when using this product ■ do not exceed recommended dosage. if nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. ■ you may get drowsy. ■ may cause excitability, especially in children. ■ alcohol, sedatives and tranquilizers may increase the drowsiness effect. ■ avoid alcoholic beverages. ■ use caution when driving a motor vehicle or operating machinery. stop use and ask a doctor if ■ symptoms do not improve within seven days ■ symptoms are accompanied by fever

When Using:

When using this product ■ do not exceed recommended dosage. if nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. ■ you may get drowsy. ■ may cause excitability, especially in children. ■ alcohol, sedatives and tranquilizers may increase the drowsiness effect. ■ avoid alcoholic beverages. ■ use caution when driving a motor vehicle or operating machinery.

Dosage and Administration:

Directions adults and children 12 years and over: 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours children under 12 years of age: ask a doctor

Stop Use:

Stop use and ask a doctor if ■ symptoms do not improve within seven days ■ symptoms are accompanied by fever

Package Label Principal Display Panel:

Carton


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.

Pharmacy also called "drugstore" is a retail shop which provides prescription drugs, among other products. At the pharmacy, a pharmacist oversees the fulfillment of medical prescriptions and is available to give advice on their offerings of over-the-counter drugs. But pharmacy is not just about filling prescriptions. It is also about promoting health awareness and contributing to the betterment of the community. Pharmacists may:
  • Prepare or supervise the dispensing of medicines, ointments and tablets.
  • Advise patients on how their medicines are to be taken or used in the safest and most effective way in the treatment of common ailments.
  • Select, give advice on and supply non-prescription medicine, sickroom supplies and other products.
  • Develop legally recognised standards, and advise on government controls and regulations concerning the manufacture and supply of medicines.
  • Work in the research and development of medicines and other health-related products.
  • Be involved in the management of pharmaceutical companies.
  • Advise members of the public and other health professionals about medicines (both prescription and over-the-counter medicines), including appropriate selection, dosage and drug interactions, potential side effects and therapeutic effects.
Patients can choose medical subspeciality from below:


© PharmacyGPS 2026
Disclaimer
Privacy Policy