Firstcare Dextromethorphan Hydrobromide, Doxylamine Succinate
Dextromethorphan Hydrobromide, Doxylamine Succinate
Uspharma Ltd
Human Otc Drug
NDC 71594-706Firstcare Dextromethorphan Hydrobromide, Doxylamine Succinate also known as Dextromethorphan Hydrobromide, Doxylamine Succinate is a human otc drug labeled by 'Uspharma Ltd'. National Drug Code (NDC) number for Firstcare Dextromethorphan Hydrobromide, Doxylamine Succinate is 71594-706. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Firstcare Dextromethorphan Hydrobromide, Doxylamine Succinate drug includes Dextromethorphan Hydrobromide - 30 mg/1 Doxylamine Succinate - 12.5 mg/1 . The currest status of Firstcare Dextromethorphan Hydrobromide, Doxylamine Succinate drug is Active.
Drug Information:
| Drug NDC: | 71594-706 |
| 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: | Firstcare Dextromethorphan Hydrobromide, Doxylamine Succinate |
| 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: | Dextromethorphan Hydrobromide, Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Uspharma Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Chewable |
| 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: | DEXTROMETHORPHAN HYDROBROMIDE - 30 mg/1
DOXYLAMINE SUCCINATE - 12.5 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: | 10 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | USpharma Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2591970
|
| 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. |
| UNII: | 9D2RTI9KYH
V9BI9B5YI2
|
| 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: | Antihistamine [EPC]
Histamine Receptor Antagonists [MoA]
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 |
|---|
| 71594-706-12 | 30 TABLET, CHEWABLE in 1 BOTTLE (71594-706-12) | 10 Feb, 2022 | 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:
Purposes cough suppressant antihistamine
Product Elements:
Firstcare dextromethorphan hydrobromide, doxylamine succinate dextromethorphan hydrobromide, doxylamine succinate coconut oil maltitol noncrystallizing sorbitol solution anhydrous citric acid sucralose fd&c red no. 40 sorbitol calcium gluconate monohydrate hydroxypropyl betadex skim milk microcrystalline cellulose corn syrup crospovidone croscarmellose sodium starch, corn mannitol carnauba wax sucrose dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine red to dark red mixed berry
Indications and Usage:
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat controls the impulse to cough to help you sleep
Warnings:
Warnings do not use to sedate a child or to make a child sleepy 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 drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especiall
Read more...y in children stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings do not use to sedate a child or to make a child sleepy 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 drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Dosage and Administration:
Directions do not take more than the recommended dose adults & children under 12 years and over take 2 chewable tablets with water every 4 hours do not exceed 10 chewable tablets in 24 hours or as directed by a doctor children under 12 years do not use
Stop Use:
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel firstcaretm ***made in usa*** ndc 71594-706-12 mixed berry flavor dextromethorphan hbr and doxylamine succinate 30mg/12.5 mg fast effective:cough relief 30 chewables soft chews bottle label
Further Questions:
Questions or comments? call 1-800-227-6151