NDC 0031-8693 Childrens Robitussin Cough And Cold Long-acting

Chlorpheniramine Maleate, Dextrometrorphan Hbr

NDC Product Code 0031-8693

NDC CODE: 0031-8693

Proprietary Name: Childrens Robitussin Cough And Cold Long-acting 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: Chlorpheniramine Maleate, Dextrometrorphan Hbr 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

NDC Code Structure

  • 0031 - Richmond Division Of Wyeth
    • 0031-8693 - Childrens Robitussin Cough And Cold Long-acting

NDC 0031-8693-12

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

NDC Product Information

Childrens Robitussin Cough And Cold Long-acting with NDC 0031-8693 is a a human over the counter drug product labeled by Richmond Division Of Wyeth. The generic name of Childrens Robitussin Cough And Cold Long-acting is chlorpheniramine maleate, dextrometrorphan hbr. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Richmond Division Of Wyeth

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 Robitussin Cough And Cold Long-acting 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.

  • CHLORPHENIRAMINE MALEATE 1 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 7.5 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: Richmond Division Of Wyeth
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: 01-01-2004 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’.

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Information for Patients

Chlorpheniramine

Chlorpheniramine is pronounced as (klor fen ir' a meen)

Why is chlorpheniramine medication prescribed?
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine he...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]

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Childrens Robitussin Cough And Cold Long-acting Product Label Images

Childrens Robitussin Cough And Cold Long-acting 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)

Chlorpheniramine maleate, USP 1 mgDextromethorphan HBr, USP 7.5 mg

Purposes

AntihistamineCough suppressant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldtemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny 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.

Ask A Doctor Before Use If You Have

  • Trouble urinating due to an enlarged prostate glandglaucomaa cough 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 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

Cough 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 4 doses in any 24-hour periodagedoseunder 6 yearsdo not use6 to under 12 years2 teaspoons every 6 hours12 years and older4 teaspoons every 6 hours

Other Information

  • Each teaspoon contains: sodium 3 mgstore at 20-25°C (68-77°F)dosage cup provided

Inactive Ingredients

Anhydrous citric acid, artificial & natural flavors, FD&C red no. 40, glycerin, lactic acid, 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 Dosing InformationChildren’s Robitussin Cough & Cold LONG-ACTINGCHLORPHENIRAMINE MALEATE (Antihistamine)DEXTROMETHORPHAN HBr (Cough Suppressant)RELIEVES:Cough: Up to 8 HoursRunny NoseFRUIT PUNCH FlavorFor Children Ages 6 & OverAlcohol-Free4 FL OZ (118 mL)Robitussin KnowsChoosing the right product is important. Robitussin has different products for adults and for children.GREEN BoxesAges 12 & OverRED BoxesAges Under 12Use as directedDOSAGE CUP INCLUDEDWyeth Consumer Healthcare Madison, NJ 07940 U.S.A. © 2009 WyethFor most recent product information, visit www.robitussin.comPARENTS: Learn about teen medicine abuse www.stopMedicineAbuse.orgPackaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

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