Nighttime Cough Relief
Dextromethorphan Hydrobromide, Doxylamine Succinate
Freds Inc
Human Otc Drug
NDC 55315-345Nighttime Cough Relief also known as Dextromethorphan Hydrobromide, Doxylamine Succinate is a human otc drug labeled by 'Freds Inc'. National Drug Code (NDC) number for Nighttime Cough Relief is 55315-345. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Nighttime Cough Relief drug includes Dextromethorphan Hydrobromide - 30 mg/30mL Doxylamine Succinate - 12.5 mg/30mL . The currest status of Nighttime Cough Relief drug is Active.
Drug Information:
| Drug NDC: | 55315-345 |
| 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: | Nighttime Cough Relief |
| 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: | Freds Inc |
| 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 - 30 mg/30mL
DOXYLAMINE SUCCINATE - 12.5 mg/30mL
|
| 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: | 31 Jul, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Apr, 2024 |
| 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: | 10 Jun, 2026 |
| 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: | Freds Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1234386
|
| 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: | 0084579128624
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 55315-345-12 | 355 mL in 1 BOTTLE, PLASTIC (55315-345-12) | 31 Jul, 2015 | 26 Apr, 2024 | 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:
Nighttime cough relief dextromethorphan hydrobromide, doxylamine succinate dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine alcohol anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 high fructose corn syrup polyethylene glycol, unspecified propylene glycol water saccharin sodium trisodium citrate dihydrate
Indications and Usage:
Uses temporarily relieves cold symptoms cough runny nose and sneezing
Warnings:
Warnings do not use 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 parkinsonâs 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 sodium-restricted diet asthma emphysema glaucoma excessive phlegm (mucus) breathing problems chronic bronchitis persistent or chronic cough cough associated with smoking trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness stop u
Read more...se and ask a doctor if redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts 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 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 parkinsonâs 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 sodium-restricted diet asthma emphysema glaucoma excessive phlegm (mucus) breathing problems chronic bronchitis persistent or chronic cough cough associated with smoking trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness stop use and ask a doctor if redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts 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 use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness
Dosage and Administration:
Directions do not take more than 4 doses in any 24-hours period measure only with dosing cup provided. do not use any other dosing device keep dosing cup with product ml = milliliter age dose adults & children 12 years & over 30 ml every 6 hours children 4 to 11 years do not use unless directed by a doctor children under 4 years do not use when using daytime and nighttime products,carefully read each label to ensure correct dosing
Stop Use:
Stop use and ask a doctor if redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel nighttime cough relief each dose (per 30 ml) of oral solution contains: 30 mg-dextromethorphan hbr- cough suppressant 12.5 mg doxylamine succinate- antihistamine sneezing, runny nose cough compare to vicks® nyquil® cough active ingredient* 10% alcohol ages 12 & over fl oz (ml) cherry flavor *this product is not manufactured or distributed by proctor & gamble, owner of the registered trademark vicks® nyquil® cough. tamper evident: do not use if printed safety seal around dosage cup or under cap is broken or missing. failure to follow these warnings could result in serious consequences. distributed by: fred's inc 4300 new getwell rd, memphis, tn 38118 www.fredsinc.com
Product label fred's nighttime cough relief dextromethorphan hbr 30 mg, doxylamine succinate 12.5 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm pst