Sleep Aid
Doxylamine Succinate
Kroger Company
Human Otc Drug
NDC 30142-386Sleep Aid also known as Doxylamine Succinate is a human otc drug labeled by 'Kroger Company'. National Drug Code (NDC) number for Sleep Aid is 30142-386. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Sleep Aid drug includes Doxylamine Succinate - 25 mg/1 . The currest status of Sleep Aid drug is Active.
Drug Information:
| Drug NDC: | 30142-386 |
| 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: | Sleep Aid |
| 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: | Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kroger Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | DOXYLAMINE SUCCINATE - 25 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: | ANDA |
| 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: | 16 Mar, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | ANDA040564 |
| 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: | Kroger Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1101446
|
| 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: | 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]
|
| 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 |
|---|
| 30142-386-27 | 2 BLISTER PACK in 1 CARTON (30142-386-27) / 16 TABLET in 1 BLISTER PACK | 16 Mar, 2021 | 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 nighttime sleep-aid
Product Elements:
Sleep aid doxylamine succinate doxylamine succinate doxylamine dibasic calcium phosphate dihydrate fd&c blue no. 1 aluminum lake magnesium stearate microcrystalline cellulose sodium starch glycolate type a potato 44;386
Indications and Usage:
Use helps to reduce difficulty in falling asleep
Warnings:
Warnings do not use in children under 12 years of age ask a doctor before use if you have glaucoma a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking any other drugs. when using this product avoid alcoholic beverages take only at bedtime stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. insomnia may be a symptom of a serious underlying medical illness. 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 in children under 12 years of age ask a doctor before use if you have glaucoma a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking any other drugs. when using this product avoid alcoholic beverages take only at bedtime stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. insomnia may be a symptom of a serious underlying medical illness. 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 avoid alcoholic beverages take only at bedtime
Dosage and Administration:
Directions adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. insomnia may be a symptom of a serious underlying medical illness.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient of unisom® sleeptabs® *see back panel ndc 30142-386-27 kroger® nighttime sleep-aid sleep aid doxylamine succinate tablets, 25 mg nighttime sleep-aid actual size one tablet per dose 32 tablets tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering *unisom® and sleeptabs® are registered trademarks of chattem, inc., chattanooga, tn 37409. chattem, inc. is not affiliated with the kroger co. or this product. distributed by the kroger co. cincinnati, ohio 45202 for more product information, scan upc using your kroger app or call 800-632-6900 50844 rev1120a38627 our brands. our guarantee. love it or your money back. www.kroger.com kroger 44-386 kroger 44-386
Further Questions:
Questions or comments? 1-800-632-6900