NDC 0031-2249 Childrens Dimetapp Multi-symptom Cold And Flu

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

NDC Product Code 0031-2249

NDC 0031-2249-04

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

NDC Product Information

Childrens Dimetapp Multi-symptom Cold And Flu with NDC 0031-2249 is a a human over the counter drug product labeled by Wyeth Consumer Healthcare Llc. The generic name of Childrens Dimetapp Multi-symptom Cold And Flu is acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride. 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 Multi-symptom Cold And Flu 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.

  • ACETAMINOPHEN 320 mg/10mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/10mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL

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)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL (UNII: L7T10EIP3A)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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
Marketing Category: UNAPPROVED DRUG OTHER - 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: 01-01-2020 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: 12-31-2021 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

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
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 Multi-symptom Cold And Flu 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

Other

Drug Facts

Distributed by:Pfizer, Madison, NJ 07940 USA

Otc - Purpose

Active ingredients (in each 10 ml)PurposesAcetaminophen, USP 320 mgPain reliever/Fever reducerDiphenhydramine HCl, USP 12.5 mgAntihistamine/Cough suppressantPhenylephrine HCl, USP 5 mgNasal decongestant

Indications & Usage

  • Usestemporarily relieves these symptoms associated with a cold, or flu: headachesore throatfeverminor aches and painstemporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a coldtemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitching of the nose or throatitchy, watery eyesrunny nosetemporarily restores freer breathing through the nose

Warnings

Warnings

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if user takesmore than 5 doses in any 24-hour period, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • To sedate a child or to make a child sleepyin a child under 6 years of ageif user is 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If User Has

  • Liver diseaseheart 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 User Is

  • Taking the blood thinning drug warfarintaking any other oral nasal decongestant or stimulanttaking any other pain reliever/fever reducertaking 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

  • User gets nervous, dizzy, or sleeplesspain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)fever gets worse or lasts more than 3 daysredness or swelling is presentcough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.new symptoms occur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Dosage & Administration

  • Directionsdo not take more than 5 doses in any 24-hour perioddo not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.measure only with dosage cup providedkeep dosage cup with productml = milliliteragedoseadults and children 12 years and over20 ml every 4 hourschildren 6 to 12 years 10 ml every 4 hourschildren under 6 years do not use

Storage And Handling

  • Other informationeach 10 ml contains: sodium 7 mgstore at 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredientsanhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Otc - Questions

Questions or comments?Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675For most recent product information, visit www.dimetapp.com

* Please review the disclaimer below.