NDC 0363-9140 Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Diphenhydramine Hcl Phenylephrine Hcl

NDC Product Code 0363-9140

NDC CODE: 0363-9140

Proprietary Name: Mucus Relief All In One Daytime Nighttime Cold 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: Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Diphenhydramine Hcl Phenylephrine Hcl 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
    • 0363-9140 - Mucus Relief All In One Daytime Nighttime Cold Flu

NDC 0363-9140-12

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

NDC Product Information

Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength with NDC 0363-9140 is a a human over the counter drug product labeled by Walgreens. The generic name of Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength is acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl phenylephrine hcl. 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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • 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)

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: 09-30-2019 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.

Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength Product Label Images

Mucus Relief All In One Daytime Nighttime Cold 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 Day Time (In Each 20 Ml)

Acetaminophen 650 mg Dextromethorphan HBr 20 mgGuaifenesin 400 mgPhenylephrine HCL 10 mg

Active Ingredients For Night Time (In Each 20 Ml)

Acetaminophen 650 mgDiphenhydramine HCL 25 mgPhenylephrine HCL 10 mg

Purposes For Day Time

Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Purpose For Night Time

Pain reliever/fever reducerAntihistamine/Cough suppressantNasal decongestant

Uses

  • Daytimetemporarily relieves these common cold and flu symptomscoughnasal congestion minor aches and painsore throatheadachestuffy nosesinus congestion and pressuretemporarily reduces feverhelp loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make cough more productiveNighttime temporarily relieves these common cold and flu symptoms
  • Coughnasal congestionminor aches and painssore throatheadachesinus congestion and pressurerunny nosesneezingitching of the nose or throatitchy, watery eyes due to hay fevertemporarily reduces fever controls cough to help you get to sleep

Warnings

  • Liver warning : This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith 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 reddeningblistersrash.If a skin reaction occurs, stop use and seek medical help right awaySore 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

  • Daytimewith 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.
  • For children under 12 years of ageNighttimeWith any other 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 skinif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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

  • Daytimeliver diseaseheart diseasediabetes thyroid diseasehigh blood pressuretrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysemacough that occurs with too much phlegm (mucus)Nighttimeliver diseaseheart diseasehigh blood pressurethyroid diseasediabetesglaucomatrouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitiscough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

  • DAYTIMEtaking the blood thinning drug warfarin.NIGHTTIMEtaking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product

  • Daytimedo not use more than directed.Nighttimedo not use more than directedexcitability may occur, especially in childrenmarked drowsinessmay occuralcohol, sedative, and tranquilizers may increase drowsinessavoid alcohol drinksbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • Daytimenervousness, dizziness or sleeplessness occurpain, nasal congestion, or cough gets worse, or lasts more than 7 daysfever gets worse, or last 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.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 fever, rash, or headache that lasts.These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use

Keep Out Of Reach Of Children.

Overdose 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 adult as well as for children even if you do not notice any signs or symptoms

Directions

  • Daytimedo not take more than directed (see Overdose warning) do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing devicekeep dosing cup with product mL= milliliterdose as follows or as directed by a doctoradult and children 12 years of age and over: 20 mL in dosing cup provided avery 4 hoursChildren under 12 years of age do not useNighttimedo 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 devicekeep dosing cup with productmL= milliliterdose as follows or as directed by a doctoradult and children 12 years and older: 20 mL every 4 hours while symptoms lastchildren under 12 years of age do not use

Other Information

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

Inactive Ingredients

Inactive ingredients for Day Time  citric 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 gumInactive ingredients for Night Time  citric acid, EDTA disodium, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Product Label

WALGREENS Daytime Nighttime Cold & Flu

* Please review the disclaimer below.