Cvs Health Childrens Allergy Relief
Diphenhydramine Hydrochloride
Cvs Pharmacy,inc.
Human Otc Drug
NDC 59779-793Cvs Health Childrens Allergy Relief also known as Diphenhydramine Hydrochloride is a human otc drug labeled by 'Cvs Pharmacy,inc.'. National Drug Code (NDC) number for Cvs Health Childrens Allergy Relief is 59779-793. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Cvs Health Childrens Allergy Relief drug includes Diphenhydramine Hydrochloride - 12.5 mg/5mL . The currest status of Cvs Health Childrens Allergy Relief drug is Active.
Drug Information:
| Drug NDC: | 59779-793 |
| 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: | Cvs Health 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 Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy,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: | 07 Sep, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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, 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: | CVS Pharmacy,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 |
|---|
| 59779-793-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (59779-793-10) / 5 mL in 1 VIAL, SINGLE-DOSE | 07 Sep, 2015 | 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:
Cvs health childrens allergy relief diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine anhydrous citric acid carboxymethylcellulose sodium glycerin potassium citrate water sodium benzoate sorbitol sucralose
Indications and Usage:
Uses ⢠temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ⢠runny nose ⢠sneezing ⢠itchy, watery eyes ⢠itching of the nose or throat
Warnings:
Warnings do not use ⢠to make a child sleepy ⢠with any other product containing diphenhydramine, even one used on skin ask a doctor before use if the child has ⢠a breathing problem such as chronic bronchitis ⢠glaucoma 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 right away. (1-800-222-1222)
Do Not Use:
Warnings do not use ⢠to make a child sleepy ⢠with any other product containing diphenhydramine, even one used on skin ask a doctor before use if the child has ⢠a breathing problem such as chronic bronchitis ⢠glaucoma 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 right away. (1-800-222-1222)
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 ⢠find right dose on chart below ⢠break tab on blister ⢠pour liquid directly into mouth or into teaspoon ⢠be careful of blister edges to prevent cuts on skin ⢠take every 4 to 6 hours ⢠do not take more than 6 doses in 24 hours age (yr) dose (tsp) 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 1 to 2 single-dose blisters(12.5mg to 25mg)
Package Label Principal Display Panel:
Principal display panel cvs health ⢠compare to the active ingredient in children's benadryl® * dye-free liquid childrenâs allergy relief liquid medication diphenhydramine hydrochloride 12.5 mg antihistamine alcohol and sugar free relief of: sneezing; runny nose; itchy, watery eyes; itchy throat cherry flavored sugar & alcohol free actual product size on side panel single dose 10 single dose vials this is not a child-resistant package. keep out of reach of children *this product is not manufactured or distributed by mcneil consumer healthcare, distributor of childrenâs benadryl® dye âfree allergy. tamper evident: do not use if any individual single-dose blister unit is broken or open distributed by: cvs pharmacy, inc. one cvs drive,woonsocket, ri 02895 © 2015cvs/pharmacy cvs.com ® 1-800-shop cvs made in the u.s.a. v-12431 cvs quality money back guarantee snap back at perforation line pour into mouth or spoon use scissors to cut blister if difficult to open. cvs health children's allergy relief 10 single dose vials