NDC 37000-539 Vicks Flu Therapy Severe Cold And Flu Day

Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

NDC Product Code 37000-539

NDC Code: 37000-539

Proprietary Name: Vicks Flu Therapy Severe Cold And Flu Day 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, Dextromethorphan Hydrobromide, And Phenylephrine 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.


Code Structure
  • 37000 - The Procter & Gamble Manufacturing Company
    • 37000-539 - Vicks Flu Therapy

NDC 37000-539-01

Package Description: 6 POUCH in 1 BLISTER PACK > 5 g in 1 POUCH

NDC Product Information

Vicks Flu Therapy Severe Cold And Flu Day with NDC 37000-539 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Vicks Flu Therapy Severe Cold And Flu Day is acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: The Procter & Gamble Manufacturing Company

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

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 Flu Therapy Severe Cold And Flu Day 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.

  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/5g
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5g
  • ACETAMINOPHEN 500 mg/5g

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.

  • ACESULFAME (UNII: MA3UYZ6K1H)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ASPARTAME (UNII: Z0H242BBR1)
  • SUCROSE (UNII: C151H8M554)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

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: 04-17-2019 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 Flu Therapy Severe Cold And Flu Day Product Label Images

Vicks Flu Therapy Severe Cold And Flu Day 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 45202

Otc - Active Ingredient

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Otc - Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

  • Temporarily relieves common cold/flu symptoms:minor aches & painssore throatfeverheadachecough due to minor throat & bronchial irritationcough to help you sleepnasal congestionsinus congestion & pressurereduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainage

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 6 doses in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day 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 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 diseasediabetescough that occurs with too much phlegm (mucus)persostent or chronic cough such as occurs with smoking, asthma, or emphysematrouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin

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 7 daysfever 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.

Overdose Warning

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

Directions

  • Take only as directeddo not exceed 6 doses per 24 hrsadults & children 12 yrs & over one packet every 4 hrs
  • Children under 12 yrs do not use
  • Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutesIf using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat

Other Information

  • Potassium 10 mgphenylketonurics: contains phenylalanine 64 mg per dosedo not exceed 25°C.

Inactive Ingredients

Acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

Questions?

1-800-362-1683

* Please review the disclaimer below.

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