NDC 37000-759 Vicks Childrens Fcold Multi Symptom

Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide

NDC Product Code 37000-759

NDC Code: 37000-759

Proprietary Name: Vicks Childrens Fcold Multi Symptom 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: Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide 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

  • 37000 - Procter & Gamble Manufacturing Company
    • 37000-759 - Vicks Childrens

NDC 37000-759-06

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Vicks Childrens Fcold Multi Symptom with NDC 37000-759 is a a human over the counter drug product labeled by Procter & Gamble Manufacturing Company. The generic name of Vicks Childrens Fcold Multi Symptom is acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Procter & Gamble Manufacturing Company

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.

Vicks Childrens Fcold Multi Symptom 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 325 mg/15mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL

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.

  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BETA CAROTENE (UNII: 01YAE03M7J)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: Procter & Gamble Manufacturing Company
Labeler Code: 37000
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: 04-23-2019 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

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]
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]
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.

Vicks Childrens Fcold Multi Symptom Product Label Images

Vicks Childrens Fcold Multi Symptom 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

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

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202Made in Canada

Active Ingredients (In Each 15 Ml)

Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer

Cough suppressant
Nasal decongestant

Uses

  • Temporarily relieves common cold/flu symptoms:nasal congestioncough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfever

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this productchild takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this producttaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks daily while using this product

Allergy Alert:

  • Acetaminophen may cause severe skin reactions. Symptoms may include:Skin reddeningBlistersRashIf a skin reaction occurs, stop use and seek medical help right away

Sore Throat Warning

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

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.if 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

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to enlarged prostate glandcough that occurs with too much phlegm (mucus)peristent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin

Otc - When Using

When using this product, do not use more than directed

Stop Use And Ask A Doctor If

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

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.

Directions

  • Take only as directedonly use the dose cup provideddo not exceed 4 doses per 24 hrsadults & children 12 yrs & over 30 mL every 4 hrschildren 6 to under 12 yrs 15 mL every 4 hrs
  • Children 4 to under 6 yrs ask a doctor
  • Children under 4 yrs do not use

Other Information

  • Each 15 mL contains: sodium 44 mg
  • Store at no greater than 25C. Do not refrigerate.

Inactive Ingredients

Anhydrous citric acid, beta carotene, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

1-800-362-1683

* Please review the disclaimer below.

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