Dye Free Childrens Diphenhydramine Hydrochloride
Diphenhydramine Hydrochloride
Precision Dose, Inc.
Human Otc Drug
NDC 68094-022Dye Free Childrens Diphenhydramine Hydrochloride also known as Diphenhydramine Hydrochloride is a human otc drug labeled by 'Precision Dose, Inc.'. National Drug Code (NDC) number for Dye Free Childrens Diphenhydramine Hydrochloride is 68094-022. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Dye Free Childrens Diphenhydramine Hydrochloride drug includes Diphenhydramine Hydrochloride - 12.5 mg/5mL . The currest status of Dye Free Childrens Diphenhydramine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 68094-022 |
| 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: | Dye Free Childrens Diphenhydramine Hydrochloride |
| 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 Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Precision Dose, 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: | DIPHENHYDRAMINE HYDROCHLORIDE - 12.5 mg/5mL
|
| 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: | 27 Dec, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 May, 2026 |
| 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: | Precision Dose, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049906
|
| 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. |
| 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 |
|---|
| 68094-022-62 | 3 TRAY in 1 CASE (68094-022-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-022-59) | 27 Dec, 2018 | 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 antihistamine
Product Elements:
Dye free childrens diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine anhydrous citric acid glycerin water sodium benzoate trisodium citrate dihydrate carboxymethylcellulose sodium, unspecified saccharin sodium sorbitol
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies sneezing runny nose itchy, watery eyes itching of the nose or throat
Warnings:
Warnings do not use with any other product containing diphenhydramine, even one used on the skin to make a child sleepy ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. when using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children 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 with any other product containing diphenhydramine, even one used on the skin to make a child sleepy ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. when using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children 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 marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children
Dosage and Administration:
Directions do not take more than 6 doses in 24 hours take every 4 to 6 hours, or as directed by a doctor ml = milliliter find the right dose on the chart below age (yr) dose (ml) children 6 to 11 years 5 ml to 10 ml children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use
How Supplied:
How supplied ndc 68094-022-61 5 ml per unit dose cup one hundred (100) cups per shipper ndc 68094-022-62 5 ml per unit dose cup thirty (30) cups per shipper ndc 68094-024-62 10 ml per unit dose cup thirty (30) cups per shipper
Package Label Principal Display Panel:
Principal display panel - 5 ml cup label ndc 68094-022-59 precisiondose⢠children's dye free diphenhydramine hcl liquid 12.5 mg/5 ml pkg: precision dose, inc., s. beloit, il 61080 principal display panel - 5 ml cup label
Further Questions:
For inquiries call precision dose, inc. at 1-800-397-9228 or email druginfo@precisiondose.com li1156 rev. 04/22