Nighttime Sleep Aid Maximum Strength
Diphenhydramine Hcl
Cardinal Health (leader) 70000
Human Otc Drug
NDC 70000-0426Nighttime Sleep Aid Maximum Strength also known as Diphenhydramine Hcl is a human otc drug labeled by 'Cardinal Health (leader) 70000'. National Drug Code (NDC) number for Nighttime Sleep Aid Maximum Strength is 70000-0426. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Nighttime Sleep Aid Maximum Strength drug includes Diphenhydramine Hydrochloride - 50 mg/1 . The currest status of Nighttime Sleep Aid Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 70000-0426 |
| 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 Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Nighttime Sleep Aid |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Maximum Strength |
| 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: | Diphenhydramine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health (leader) 70000 |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| 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 - 50 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: | 28 Feb, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Dec, 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: | part338 |
| 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: | 15 Jan, 2025 |
| 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: | Cardinal Health (Leader) 70000
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1020477
|
| 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: | 0096295135596
|
| 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 |
|---|
| 70000-0426-1 | 1 BOTTLE, PLASTIC in 1 BOX (70000-0426-1) / 32 CAPSULE in 1 BOTTLE, PLASTIC | 28 Feb, 2019 | 27 Dec, 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:
Purpose nighttime sleep-aid
Product Elements:
Nighttime sleep aid maximum strength diphenhydramine hcl diphenhydramine hydrochloride diphenhydramine fd&c blue no. 1 gelatin glycerin propylene glycol polyethylene glycol, unspecified water sorbitan sorbitol p50;a99;d50;ap018
Indications and Usage:
Use for 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 ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product avoid alcoholic drinks. 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. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
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 ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product avoid alcoholic drinks. 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. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
When Using:
When using this product avoid alcoholic drinks.
Dosage and Administration:
Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
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 unisom® sleepgels® active ingredient sleep aid diphenhydramine hcl, 50 mg | nighttime sleep-aid for relief of occasional sleeplessness non-habit-forming softgels** **one softgel per dose **this product is not manufactured or distributed by chattem, inc., distributor of unisom® sleepgels®. tamper evident: do not use if printed safety seal under cap is broken or missing. keep outer carton for complete warnings and product information. distributed by cardinal health dublin, ohio 43017 www.myleader.com 1-800-200-6313
Package label leader sleep aid diphenhydramine hci 50 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est