NDC 0031-2247 Childrens Dimetapp Nighttime Cold And Congestion

Diphenhydramine Hcl, Phenylephrine Hcl

NDC Product Code 0031-2247

NDC CODE: 0031-2247

Proprietary Name: Childrens Dimetapp Nighttime Cold And 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 Hcl, Phenylephrine Hcl 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.

NDC Code Structure

  • 0031 - Wyeth Consumer Healthcare Llc
    • 0031-2247 - Childrens Dimetapp Nighttime Cold And Congestion

NDC 0031-2247-13

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

NDC Product Information

Childrens Dimetapp Nighttime Cold And Congestion with NDC 0031-2247 is a a human over the counter drug product labeled by Wyeth Consumer Healthcare Llc. The generic name of Childrens Dimetapp Nighttime Cold And Congestion is diphenhydramine hcl, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Wyeth Consumer Healthcare Llc

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 Dimetapp Nighttime Cold And 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 6.25 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL

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.
  • 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: Wyeth Consumer Healthcare Llc
Labeler Code: 0031
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: 11-01-2007 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* 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 Dimetapp Nighttime Cold And Congestion Product Label Images

Childrens Dimetapp Nighttime Cold And 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 Ingredients (In Each 5 Ml Tsp)

Diphenhydramine HCl, USP 6.25 mgPhenylephrine HCl, USP 2.5 mg

Purposes

Antihistamine/Cough suppressantNasal decongestant

Uses

  • Temporarily relieves these symptoms occurring with a cold, hay fever, or other upper respiratory allergies:nasal congestioncoughrunny nosesneezingitchy, watery eyesitching of the nose or throat

Do Not Use

  • To sedate a child or to make a child sleepyIf you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, 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.with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • Heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking any other oral nasal decongestant or stimulanttaking sedatives or tranquilizers

When Using This Product

  • Do not use more than directedmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Stop Use And Ask A Doctor If

  • You get nervous, dizzy, or sleeplesssymptoms do not get better within 7 days or are accompanied by fevercough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Do not take more than 6 doses in any 24-hour perioddo not exceed recommended dosageagedoseadults and children 12 years and over 4 tsp every 4 hourschildren 6 to under 12 years 2 tsp every 4 hourschildren under 6 years do not use

Other Information

  • Each teaspoon contains: sodium 4 mgstore at 20 -25°C (68 -77°F)dosage cup provided

Inactive Ingredients

Anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Product Packaging

  • The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.SEE NEW WARNING INFORMATIONChildren’s Dimetapp Nighttime Cold & CongestionDIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)PHENYLEPHRINE HCl (Nasal Decongestant)Relieves Nasal SymptomsStuffy NoseRunny NoseSneezingPlus Other SymptomsItchy, Watery EyesCoughFor Ages 6 Yrs. & Over4 FL OZ (118 mL) grape flavorFor most recent product information, visit www.dimetapp.comWe pledge to you that Dimetapp products contain only high quality ingredients and meet strict standards of quality and safety. You can trust Dimetapp products for your family.Dosage Cup ProvidedWyethWyeth Consumer HealthcareMadison, NJ 07940 USA©2009 WyethPackaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

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