NDC 0363-0463 Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu Maximum Strength

Daytime Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Nighttime Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci

NDC Product Code 0363-0463

NDC CODE: 0363-0463

Proprietary Name: Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu Maximum Strength 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: Daytime Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Nighttime Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci 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

  • 0363 - Walgreens
    • 0363-0463 - Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu

NDC 0363-0463-12

Package Description: 1 KIT in 1 KIT * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu Maximum Strength with NDC 0363-0463 is a a human over the counter drug product labeled by Walgreens. The generic name of Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu Maximum Strength is daytime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, nighttime acetaminophen, diphenhydramine hci, phenylephrine hci. The product's dosage form is kit and is administered via form.

Labeler Name: Walgreens

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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walgreens
Labeler Code: 0363
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: 03-31-2016 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]
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]
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]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[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.

Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu Maximum Strength 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

Active Ingredients For Nighttime (In Each 20 Ml)

Acetaminophen 650 mgDiphenhydramine HCI 25 mg Phenylephrine HCI 10 mg

Active Ingredients For Daytime (In Each 20 Ml)

Acetaminophen 650 mgDextromethorphan HBr 20 mgGuaifeenesin 400 mgPhenylephrine HCl 10 mg

Purpose For Nighttime

Pain reliever/fever reducerAntihistamine/cough suppressantNasal decongestant

Purpose For Daytime

Pain reliever / fever reducer Cough suppressantExpectorantNasal decongestant

Uses

  • Nighttimetemporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleepDaytimetemporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Warnings

  • NIGHTTIME and DAYTIME Liver warning: This product contain acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddening blisters rash.If 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

  • Nighttimewith any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on the skin 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 for children under 12 years of ageDaytimewith any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.for children under 12 years of ageif you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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

  • Nighttimeliver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)Daytimeliver disease heart diseasehigh blood pressure thyroid disease diabetes trouble urinating due to an enlarged gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

  • Nighttimeyou are taking the blood thinning drug warfarin you are taking sedative or tranquilizersDaytimetaking the blood thinning drug warfarin

When Using These Products

  • Nighttimedo not use more than directedexcitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicile or operating machineryDaytimedo not use more than directed

Stop Use And Ask A Doctor If

  • Nighttimenervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be a signs of a serious condition Daytimenervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or lasts more than 3 days redness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Nighttime and DayTimeask a health professional before use.

Keep Out Of Reach Of Children.

Nighttime and DayTimeOverdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

  • Nighttimedo not take more than directed (see overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = mililiter dose as follows or as directed by a doctor adults and children 12 years and older: 20 mL every 4 hours while symptoms last children under 12 years of age: do not useDaytimedo not take more than directed (see Overdose warning)do not take more than 6 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device. dose as follows or as directed by a doctor  keep dosing cup with product  mL = milliliter adults and children 12 years of age and older: 20 mL every 4 hours children under 12 years of age: do not use

Other Information

  • Nighttimeeach 20 mL contains: sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.Daytimeeach 20 mL contains: 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

Nighttimecitric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gumDaytimecitric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Product Label

WALGREENS Night Time Cold & Flu Maximum Strength, Day Time Severe Cold Maximum Strength

* Please review the disclaimer below.