NDC 42507-049 Childrens Allergy Plus Congestion

Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

NDC Product Code 42507-049

NDC CODE: 42507-049

Proprietary Name: Childrens Allergy Plus Congestion 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.

Non-Proprietary Name: Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride 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.

Product Characteristics

Flavor(s):
GRAPE (C73391)

NDC Code Structure

  • 42507 - Hy-vee
    • 42507-049 - Childrens Allergy Plus Congestion

NDC 42507-049-04

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 118 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Childrens Allergy Plus Congestion with NDC 42507-049 is a a human over the counter drug product labeled by Hy-vee. The generic name of Childrens Allergy Plus Congestion is diphenhydramine hydrochloride, phenylephrine hydrochloride. The product's dosage form is liquid and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1086720.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Childrens Allergy Plus Congestion Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SUCROSE (UNII: C151H8M554)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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.

Labeler Name: Hy-vee
Labeler Code: 42507
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 04-30-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2021 What is the End Marketing Date?
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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Childrens Allergy Plus Congestion Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each 5 Ml)

Diphenhydramine HCl 12.5 mgPhenylephrine HCI 5 mg

Purpose

AntihistamineNasal decongestant

Uses

  • Temporarily relieves these symptoms due to hay fever, the common cold, or other upper respiratory allergies
  • Runny nose sneezing
  • Stuffy noseitchy, watery eyes itching of the nose or throat
  • ​nasal congestion temporarily relieves sinus congestion and pressure

Do Not Use

  • To sedate a child or to make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If The Child Has

  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Glaucoma
  • Trouble urinating due to an enlarged prostate gland
  • A breathing problem such as emphysema or chronic brochitis

Ask A Doctor Or Pharmacist Before Use If The Child Is

Taking sedatives or tranquilizers.

When Using This Product

  • Do not exceed recommended dose
  • Marked drowsiness may occur
  • Avoid alcoholic beverages
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery
  • Excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • Nervousness,dizziness or sleeplessness occur
  • Symptoms do not get better within 7 days or are accompanied by fever

If Pregnant Or Breast-Feeding,

Ask a health professional before use

Keep Out Of The Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Do not take more than 6 doses in any 24-hour period
  • Measure only with dosing cup provided. Do not use any other dosing device.
  • Keep dosing cup with product
  • ML = milliliter
  • Shake well before usingAge Dose children under 4 years do not use children 4 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL every 4 hours adults and children 12 years and over 10 mL every 4 hours

Other Information

  • Each 5 mL contains: sodium 8 mg
  • Store between 20-25ºC (68-77ºF)
  • Do not refrigerate. Protect from light.

Inactive Ingredients

Anhydrous citric acid,carboxymethylcellulose sodium, disodium EDTA, FD&C blue#1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate,  sorbital, sucralose, trisodium citrate dihydrate

Product Label

Hy-Vee health Children's Allergy + Congestion

* Please review the disclaimer below.