NDC 68788-7994 Good Neighbor Pharmacy Childrens Allergy
Diphenhydramine Hydrochloride Solution Oral

Product Information

Product Code68788-7994
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Good Neighbor Pharmacy Childrens Allergy
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Diphenhydramine Hydrochloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Preferred Pharmaceuticals Inc.
Labeler Code68788
FDA Application Number What is the FDA Application Number?
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.
part341
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-09-2021
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)RED (C48326 - BLUISH-RED)
Flavor(s)CHERRY (C73375)

Product Packages

NDC 68788-7994-1

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

Product Details

Good Neighbor Pharmacy Childrens Allergy is a human over the counter drug product labeled by Preferred Pharmaceuticals Inc.. The generic name of Good Neighbor Pharmacy Childrens Allergy is diphenhydramine hydrochloride. The product's dosage form is solution and is administered via oral form.


What are Good Neighbor Pharmacy Childrens Allergy Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Good Neighbor Pharmacy Childrens Allergy Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient (In Each 5 Ml)



Diphenhydramine HCl 12.5 mg


Purpose



Antihistamine


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

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).


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.


Other Information



  • each 5 mL (1 tsp) contains: sodium 15 mg
  • •store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • •do not use if printed neckband is broken or missing

Inactive Ingredients



anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to Children’s Benadryl® Allergy active ingredient

children’s

Allergy

Antihistamine

12.5 mg/5 mL

diphenhydramine HCl

oral solution

For Allergy Relief

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat

4-6 Hours/Dose

Alcohol Free

Cherry Flavored

4 fl oz (118 mL)


* Please review the disclaimer below.