Honeyworks Plus Adult Nighttime Cough Syrup
Dextromethorphan Hbr, Doxylamine Succinate
Raritan Pharmaceuticals Inc
Human Otc Drug
NDC 68163-660Honeyworks Plus Adult Nighttime Cough Syrup also known as Dextromethorphan Hbr, Doxylamine Succinate is a human otc drug labeled by 'Raritan Pharmaceuticals Inc'. National Drug Code (NDC) number for Honeyworks Plus Adult Nighttime Cough Syrup is 68163-660. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Honeyworks Plus Adult Nighttime Cough Syrup drug includes Dextromethorphan Hydrobromide - 20 mg/20mL Doxylamine Succinate - 12.5 mg/20mL . The currest status of Honeyworks Plus Adult Nighttime Cough Syrup drug is Active.
Drug Information:
| Drug NDC: | 68163-660 |
| 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: | Honeyworks Plus Adult Nighttime Cough Syrup |
| 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, Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Raritan Pharmaceuticals 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 - 20 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: | 01 Feb, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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, 2024 |
| 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: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | |
| 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 |
|---|
| 68163-660-08 | 1 BOTTLE in 1 CARTON (68163-660-08) / 236 mL in 1 BOTTLE | 01 Feb, 2023 | 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:
Active ingredients (in each 20 ml) purposes dextromethorphan hbr, usp 20 mg cough suppressant doxylamine succinate, usp 12.5 mg antihistamine
Product Elements:
Honeyworks plus adult nighttime cough syrup dextromethorphan hbr, doxylamine succinate dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine anhydrous citric acid honey water sodium benzoate
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 dri
Read more...ving 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.
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 ⪠measure only with dosing cup provided ⪠keep dosing cup with product ⪠ml = milliliter ⪠do not take more than 4 doses in any 24-hour period ⪠this adult products is not intended for use in children under 12 years of age age dose adults and children 12 years and older 20 ml every 6 hours 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 - 118 ml bottle carton ndc 68163-660-08 honeyworks⢠plus adult cough syrup dextromethorphan hbr (cough suppressant) doxylamine succinate (antihistamine) nighttime formula this great-tasting product offers fast & effective cough relief nad is made with organic dark honey ⢠no parabens ⢠no dyes ⢠no high fructose corn syrup ⢠no artificial flavors ⢠non-gmo ⢠soy-free ⢠gluten free ⢠dairy-free ⢠peanut-free ⢠tree nut-free ⢠zero trans fat for ages 12 years & older also try honeyworks⢠kids soothing throat spray 8 fl oz (236 ml) important: keep this carton for future reference on full labeling. honeyworks adult nt cough dm 8 fl oz (236 ml)
Further Questions:
Questions or comments? 1-866-467-2748