NDC 37000-934 Vicks Dayquil Severe And Vicks Nyquil Severe Cold And Flu

Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Guaifenesin And Doxylamine Succinate

NDC Product Code 37000-934

NDC Code: 37000-934

Proprietary Name: Vicks Dayquil Severe And Vicks Nyquil Severe Cold And Flu 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, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Guaifenesin And Doxylamine Succinate 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
    • 37000-934 - Vicks Dayquil Severe And Vicks Nyquil Severe

NDC 37000-934-12

Package Description: 1 KIT in 1 PACKAGE * 1 BLISTER PACK in 1 CARTON > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Vicks Dayquil Severe And Vicks Nyquil Severe Cold And Flu with NDC 37000-934 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Vicks Dayquil Severe And Vicks Nyquil Severe Cold And Flu is acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, guaifenesin and doxylamine succinate. The product's dosage form is kit and is administered via form.

Labeler Name: The Procter & Gamble Manufacturing Company

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • AMMONIA (UNII: 5138Q19F1X)
  • SHELLAC (UNII: 46N107B71O)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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: 07-04-2019 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 Dayquil Severe And Vicks Nyquil Severe Cold And Flu Product Label Images

Vicks Dayquil Severe And Vicks Nyquil Severe 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

DayQuil™ SEVERE Cold & FluDrug Facts

NyQuil™ SEVERE Cold & FluDrug Facts

Made in Canada




DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202

Otc - Active Ingredient

Acetaminophen 325 mg




Dextromethorphan HBr 10 mg




Guaifenesin 200 mg




Phenylephrine HCl 5 mg

Otc - Purpose

Pain reliever/Fever reducer




Cough suppressant




Expectorant




Nasal decongestant

Uses

  • Temporarily relieves common cold/flu symptoms:nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationminor aches & painsheadachefeversore throatreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

  • Temporarily relieves common cold/flu symptoms:nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationcough to help you sleepminor aches & painsheadachefeversore throatrunny nose & sneezingreduces 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 8 LiquiCaps in 24 hrs, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 8 LiquiCaps in 24 hrs, 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

  • 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.

  • 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)persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabeteglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysematrouble urinating due to enlarged prostate gland

Otc - Ask Doctor/Pharmacist

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 get worse or last 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.

  • 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.

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

Otc - Keep Out Of Reach Of Children

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.

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 8 LiquiCaps per 24 hrsadults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs
  • Children 4 to under 12 yrs ask a doctor
  • Children under 4 yrs do not use

  • Take only as directeddo not exceed 8 LiquiCaps per 24 hoursadults & children 12 yrs & over 2 LiquiCaps with water every 4 hrschildren 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use

Other Information

  • Do not exceed 25ºC

  • Do not exceed 25°C

Inactive Ingredients

Ammonium hydroxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerine, polyethylene glycol, povidone, propylene glycol, purified water, shellac, simethicone, sorbitol sorbitan solution, titanium dioxide

FD&C Blue No. 1, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *May contain this ingredient

Questions?

1-800-362-1683

1-800-362-1683

Active Ingredients (In Each Liquicap)

Acetaminophen 325 mg




Dextromethorphan HBr 10 mg




Doxylamine succinate 6.25 mg



Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducerCough suppressantAntihistamineNasal decongestant

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.

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking sedatives or tranquilizerstaking the blood thinning drug warfarin

When Using This Product

  • Do not use more than directedexcitability may occur, especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful when driving a motor vehicle or operating machineryalcohol, sedatives, & tranquilizers may increase drowsiness

* Please review the disclaimer below.

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