Sound Body Childrens Allergy Relief
Diphenhydramine Hcl
Big Lots Stores, Inc.
Human Otc Drug
NDC 50594-013Sound Body Childrens Allergy Relief also known as Diphenhydramine Hcl is a human otc drug labeled by 'Big Lots Stores, Inc.'. National Drug Code (NDC) number for Sound Body Childrens Allergy Relief is 50594-013. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Sound Body Childrens Allergy Relief drug includes Diphenhydramine Hydrochloride - 12.5 mg/5mL . The currest status of Sound Body Childrens Allergy Relief drug is Active.
Drug Information:
| Drug NDC: | 50594-013 |
| 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: | Sound Body Childrens Allergy 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: | Diphenhydramine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Big Lots Stores, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | 12 Jan, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 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: | Big Lots Stores, 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 50594-013-26 | 1 BOTTLE in 1 CARTON (50594-013-26) / 118 mL in 1 BOTTLE | 12 Jan, 2016 | 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:
Sound body childrens allergy relief diphenhydramine hcl diphenhydramine hydrochloride diphenhydramine anhydrous citric acid d&c red no. 33 fd&c red no. 40 high fructose corn syrup poloxamer 407 water sodium benzoate sodium chloride sodium citrate sorbitol glycerin bluish-red
Indications and Usage:
Uses ⢠temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ⢠sneezing ⢠itching of the nose or throat ⢠runny nose ⢠itchy, watery eyes
Warnings:
Warnings do not use ⢠with any other product containing diphenhydramine, even one used on 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 ⢠excitability may occur, especially in children ⢠sedatives and tranquilizers may increase drowsiness 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 ⢠with any other product containing diphenhydramine, even one used on 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 ⢠excitability may occur, especially in children ⢠sedatives and tranquilizers may increase drowsiness 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 ⢠marked drowsiness may occur ⢠excitability may occur, especially in children ⢠sedatives and tranquilizers may increase drowsiness
Dosage and Administration:
Directions ⢠find right dose on chart below ⢠ml = milliliter ⢠take every 4 to 6 hours, or as directed by a doctor ⢠do not take more than 6 doses in 24 hours age (yr) dose (ml) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 ml to 10 ml attention: use only enclosed dosing cup specifically designed for use with this product. do not use any other dosing device.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient in childrenâs benadryl® allergy liquid relief of: runny nose â sneezing itchy, watery eyes itchy throat or nose childrenâs allergy relief diphenhydramine hcl 12.5 mg / 5 ml oral solution antihistamine 4-6 hours/dose alcohol free cherry flavor 4 fl oz (118 ml) children's allergy relief image
Further Questions:
Questions or comments? 1-800-719-9260