NDC 37000-895 Vicks Childrens Cough Congestion

Phenylephrine Hydrochlorice And Diphenhydramine Hydrochloride

NDC Product Code 37000-895

NDC Code: 37000-895

Proprietary Name: Vicks Childrens Cough 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: Phenylephrine Hydrochlorice And Diphenhydramine 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.

NDC Code Structure

  • 37000 - The Procter & Gamble Manufacturing Company
    • 37000-895 - Vicks Childrens

NDC 37000-895-06

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Vicks Childrens Cough Congestion with NDC 37000-895 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Vicks Childrens Cough Congestion is phenylephrine hydrochlorice and diphenhydramine hydrochloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: The 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 Cough 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.

  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
  • GUAIFENESIN 200 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.

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

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: The 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: 04-22-2019 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.

Vicks Childrens Cough Congestion Product Label Images

Vicks Childrens Cough 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

Other

Drug Facts

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

Active Ingredients (In Each 15 Ml)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Cough suppressant

Expectorant
Nasal decongestant

Uses

  • Temporarily relieves common cold symptoms:nasal congestioncough due to minor throat and bronchial irritationhelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Do Not Use

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

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

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 sleeplesssymptoms do not improve within 7 days or occur with a fevercough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache
  • 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.

Overdose Warning

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

Directions

  • Take only as directeduse dose cup provideddo not exceed 4 doses per 24 hrs
  • Adults & children 12 yrs & over 30 mL every 4 hrs
  • Children 6 to under 12 yrs 15 mL every 4 hrs
  • Children 4 to under 6 yrs 7.5 mL every 4 hrs
  • Children under 4 yrs do not use

Other Information

  • Each 15 mL contains: sodium 44 mg
  • Store at no greater than 25ºC.

Inactive Ingredients

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

Questions?

1-800-362-1683

* Please review the disclaimer below.

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