Tussin Dm Max Nighttime
Dextromethorphan Hbr, Doxylamine Succinate
Wal-mart Stores Inc
Human Otc Drug
NDC 49035-943Tussin Dm Max Nighttime also known as Dextromethorphan Hbr, Doxylamine Succinate is a human otc drug labeled by 'Wal-mart Stores Inc'. National Drug Code (NDC) number for Tussin Dm Max Nighttime is 49035-943. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Tussin Dm Max Nighttime drug includes Dextromethorphan Hydrobromide - 30 mg/20mL Doxylamine Succinate - 12.5 mg/20mL . The currest status of Tussin Dm Max Nighttime drug is Active.
Drug Information:
| Drug NDC: | 49035-943 |
| 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: | Tussin Dm Max Nighttime |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Tussin Dm Max |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Nighttime |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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, Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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/20mL
DOXYLAMINE SUCCINATE - 12.5 mg/20mL
|
| 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: | 15 Aug, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | Wal-Mart Stores Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1115329
|
| 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 |
|---|
| 49035-943-19 | 1 BOTTLE in 1 CARTON (49035-943-19) / 237 mL in 1 BOTTLE | 15 Aug, 2018 | 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 cough suppressant antihistamine
Product Elements:
Tussin dm max nighttime dextromethorphan hbr, doxylamine succinate dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin high fructose corn syrup polyethylene glycol, unspecified propylene glycol water sodium benzoate sodium chloride trisodium citrate dihydrate sucralose sucrose xanthan gum maroon
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: itching of the nose or throat runny nose itchy, watery eyes sneezing controls the impulse to cough to help you sleep
Warnings:
Warnings do not use 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 a cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem or persistent or chronic cough 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 exceed recommended dosage marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and
Read more... ask a doctor if cough persists more than 7 days, 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 reach of children. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
Do Not Use:
Warnings do not use 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 a cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem or persistent or chronic cough 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 exceed recommended dosage marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if cough persists more than 7 days, 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 reach of children. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product do not exceed recommended dosage marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children
Dosage and Administration:
Directions do not take more than 4 doses in any 24-hour period ml = milliliter; fl oz = fluid ounce use only enclosed dosing cup designed for use with this product. do not use any other dosing device. adults and children 12 years and over: 20 ml in dosing cup provided every 6 hours children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel equate⢠ndc 49035-943-19 compare to robitussin® maximum strength nighttime cough dm active ingredients â maximum strength nighttime tussin dm max dextromethorphan hbr - cough suppressant doxylamine succinate - antihistamine nighttime cough dm relief of: ⢠cough ⢠itchy throat ⢠runny nose ages 12 + alcohol-free dosage cup included 8 fl oz (237 ml) tamper evident: do not use if imprinted safety seal under cap is broken or missing tamper evident: do not use if printed neck wrap is broken or missing parents: learn about teen medicine abuse www.stopmedicineabuse.org satisfaction guaranteed â or weâll replace it or give you your money back. for questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915 . distributed by: walmart inc., bentonville, ar 72716 â this product is not manufactured or distributed by wyeth llc, owner of the registered trademark robitussin® maximum strength nighttime cough dm. 50844 org031804319 equate 44-043 equate 44-043
Further Questions:
Questions or comments? 1-888-287-1915