Maximum Strength Adult Allergy Relief
Diphenhydramine Hcl
Aptapharma Inc.
Human Otc Drug
NDC 76281-319Maximum Strength Adult Allergy Relief also known as Diphenhydramine Hcl is a human otc drug labeled by 'Aptapharma Inc.'. National Drug Code (NDC) number for Maximum Strength Adult Allergy Relief is 76281-319. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Maximum Strength Adult Allergy Relief drug includes Diphenhydramine Hydrochloride - 50 mg/20mL . The currest status of Maximum Strength Adult Allergy Relief drug is Active.
Drug Information:
| Drug NDC: | 76281-319 |
| 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: | Maximum Strength Adult 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: | Aptapharma 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 - 50 mg/20mL
|
| 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 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | AptaPharma 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 |
|---|
| 76281-319-26 | 237 mL in 1 BOTTLE (76281-319-26) | 01 Nov, 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 diphenhydramine hcl ............................. antihistamine
Product Elements:
Maximum strength adult allergy relief diphenhydramine hcl diphenhydramine hydrochloride diphenhydramine anhydrous citric acid water sodium benzoate sucrose
Indications and Usage:
Uses â temporarily relieves these symptoms due to hay fever or other respiratory allergies: ⢠sneezing ⢠itching of the nose or throat ⢠runny nose ⢠itchy watery eyes â temporarily relieves these symptoms due to the common cold: ⢠sneezing ⢠runny nose
Warnings:
Warnings do not use ⢠with any other product containing diphenhydramine, even one used on skin ⢠to make a child sleepy
When Using:
When using this product ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠sedatives and tranquilizers may increase drowsiness ⢠be careful when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children
Dosage and Administration:
Directions ⢠if needed, take every 4-6 hours, or as directed by a doctor ⢠do not take more than 6 doses in 24 hours ⢠not to exceed 300 mg in 24 hours ⢠ml=milliliter age dose adults and children 12 years and older 10 ml to 20 ml children under 12 years of age consult a doctor
Package Label Principal Display Panel:
Principal display panel cvs health tm compare to the active ingredient in benadryl ® allergy* maximum strength adult allergy relief liquid medication free of alcohol, dyes & artificial sweeteners diphenhydramine hcl oral solution antihistamine relieves: ⢠sneezing; runny nose ⢠itchy, watery eyes ⢠itchy throat cherry flavor for ages 12 and over 8 fl oz (237 ml) do not use if imprinted shrink band is missing or broken failure to follow these warnings could result in serious consequences *this product is not manufactured or distributed by mcneil consumer healthcare, distributor of benadryl ®â allergy. lot: exp: lr-118 #344121 0 50428 60619 3 drug facts â continued on back peel here distributed by: cvs pharmacy, inc. one cvs drive, woonsocket, ri 02895 © 2018 cvs/pharmacy cvs.com ® 1-800-shop cvs v-34801 âcvs ® quality money back guarantee maximum strength adult allergy relief by cvs pharmacy, inc. res cvs alrgymaxstrngth -319
Further Questions:
Questions? call weekdays from 9:30 am to 4:30 pm est at 1-877-798-5944