Miclara Dm
Dextromethorphan Hbr, Phenylephrine Hcl, Triprolidine Hcl
Key Therapeutics
Human Otc Drug
NDC 70868-740Miclara Dm also known as Dextromethorphan Hbr, Phenylephrine Hcl, Triprolidine Hcl is a human otc drug labeled by 'Key Therapeutics'. National Drug Code (NDC) number for Miclara Dm is 70868-740. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Miclara Dm drug includes Dextromethorphan Hydrobromide - 20 mg/5mL Phenylephrine Hydrochloride - 10 mg/5mL Triprolidine Hydrochloride - 2.5 mg/5mL . The currest status of Miclara Dm drug is Active.
Drug Information:
| Drug NDC: | 70868-740 |
| 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: | Miclara Dm |
| 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 Hbr, Phenylephrine Hcl, Triprolidine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Key Therapeutics |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 20 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE - 10 mg/5mL
TRIPROLIDINE HYDROCHLORIDE - 2.5 mg/5mL
|
| 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: | 01 Sep, 2020 |
| 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: | Key Therapeutics
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1492052
|
| 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
04JA59TNSJ
YAN7R5L890
|
| 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]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| 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 |
|---|
| 70868-740-16 | 473 mL in 1 BOTTLE (70868-740-16) | 01 Sep, 2020 | 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
Product Elements:
Miclara dm dextromethorphan hbr, phenylephrine hcl, triprolidine hcl citric acid monohydrate methylparaben potassium citrate propylene glycol propylparaben water sorbitol sucralose dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine triprolidine hydrochloride triprolidine
Indications and Usage:
Uses temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages
Warnings:
Warnings do not exceed recommended dosage. 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 drug contains an maoi, ask a doctor or pharmacist before giving this product. ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease high blood pressure a cough that occurs with too much phlegm (mucus) a persistent chronic cough such occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor before use if you are taking sedatives or tranquilizers. when using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving
Read more... a motor vehicle or operating machinery stop use and ask a doctor if new symptoms occur nervousness, dizziness, or sleeplessness occur cough or nasal congestion lasts for more than 1 week, tends to recur or is accompanied by a 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 the reach of children. in case of accidental overdose seek professional help or contact a poison control center immediately.
Do Not Use:
Warnings do not exceed recommended dosage. 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 drug contains an maoi, ask a doctor or pharmacist before giving this product. ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease high blood pressure a cough that occurs with too much phlegm (mucus) a persistent chronic cough such occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor before use if you are taking sedatives or tranquilizers. when using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if new symptoms occur nervousness, dizziness, or sleeplessness occur cough or nasal congestion lasts for more than 1 week, tends to recur or is accompanied by a 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 the reach of children. in case of accidental overdose seek professional help or contact a poison control center immediately.
When Using:
When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not exceed recommended dosage. age dose adults and children 12 years of age and older: 1 teaspoonful (5ml) every 4 hours, not to exceed 4 teaspoonfuls (20ml) in a 24-hour period or as directed by a doctor children 6 to under 12 years of age: ½ teaspoonful (2.5ml) every 4 hours, not to exceed 2 teaspoonfuls (10ml) in a 24-hour period or as directed by a doctor children under 6 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if new symptoms occur nervousness, dizziness, or sleeplessness occur cough or nasal congestion lasts for more than 1 week, tends to recur or is accompanied by a fever, rash, or persistent headache. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use.
Package Label Principal Display Panel:
Principal display panel ndc 70868-740-16 miclara dm bubble gum flavor 16 fl oz (473 ml) pricipal display panel ndc 70868-740-16 miclara dm bubble gum flavor 16 fl oz (473 ml)
Further Questions:
Questions? comments? serious side effects associated with use of this product may be reported to this number. call 1-888-981-8337 mon - fri (8 a.m. to 5 p.m. cst)