Nighttime Sleep Aid
Diphenhydramine Hcl 25 Mg
Health Pharma Usa Llc
Human Otc Drug
NDC 71679-110Nighttime Sleep Aid also known as Diphenhydramine Hcl 25 Mg is a human otc drug labeled by 'Health Pharma Usa Llc'. National Drug Code (NDC) number for Nighttime Sleep Aid is 71679-110. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Nighttime Sleep Aid drug includes Diphenhydramine Hydrochloride - 25 mg/1 . The currest status of Nighttime Sleep Aid drug is Active.
Drug Information:
| Drug NDC: | 71679-110 |
| 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 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: | Diphenhydramine Hcl 25 Mg |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Health Pharma Usa Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| 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: | DIPHENHYDRAMINE HYDROCHLORIDE - 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: | 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 Jan, 2022 |
| 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: | 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: | Health Pharma USA LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049630
|
| 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: | 0371679110063
0371679110100
|
| UPC stands for Universal Product Code. |
| UNII: | TC2D6JAD40
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [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 |
|---|
| 71679-110-06 | 600 TABLET, COATED in 1 BOTTLE (71679-110-06) | 01 Jan, 2022 | N/A | No |
| 71679-110-10 | 1000 TABLET, COATED in 1 BOTTLE (71679-110-10) | 01 Jan, 2022 | 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:
Nighttime sleep aid diphenhydramine hcl 25 mg polyethylene glycol, unspecified silicon dioxide croscarmellose sodium anhydrous dibasic calcium phosphate magnesium stearate cellulose, microcrystalline titanium dioxide polyvinyl alcohol talc diphenhydramine hydrochloride diphenhydramine fd&c blue no. 1 fd&c blue no. 2 s25
Indications and Usage:
Uses provides relief of occasional sleeplessness
Warnings:
Warnings do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma heart disease ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid when using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. if pregnant or breast-feeding ask a health professional before use
Read more.... keep out of reach of children. overdose warning: taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma heart disease ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid when using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if sleeplessness persists continuously for more than 2 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. overdose warning: taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not take more than directed (see overdose warning) adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness.
Package Label Principal Display Panel:
Principal display panel compare to tylenol® simply sleep active ingredients* * this product is not manufactured or distributed by mcneil consumer healthcare, owner of the registered trademark simply sleep®. diphenhydramine hcl tablets, 25 mg ndc 71679-110-06 ndc 71679-110-10 nighttime sleepaid-600s nighttime sleepaid-1000s
Further Questions:
Questions or comments? call toll free 1-844-832-1138 monday through friday 9am 5pm est or www.healthpharma.us