NDC 0363-3998 Mucus Relief Dm And Overnight Cold And Flu

Dextromethorphan Hbr, Guaifenesin, Acetaminophen And Triprolidine Hcl

NDC Product Code 0363-3998

NDC CODE: 0363-3998

Proprietary Name: Mucus Relief Dm And Overnight 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: Dextromethorphan Hbr, Guaifenesin, Acetaminophen And Triprolidine 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.

Product Characteristics

Color(s):
BLUE (C48333)

NDC Code Structure

  • 0363 - Walgreens Co
    • 0363-3998 - Mucus Relief Dm And Overnight Cold And Flu

NDC 0363-3998-12

Package Description: 1 KIT in 1 CARTON * 180 mL in 1 BOTTLE * 180 mL in 1 BOTTLE

NDC Product Information

Mucus Relief Dm And Overnight Cold And Flu with NDC 0363-3998 is a a human over the counter drug product labeled by Walgreens Co. The generic name of Mucus Relief Dm And Overnight Cold And Flu is dextromethorphan hbr, guaifenesin, acetaminophen and triprolidine hcl. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1020138, 2173667 and 2287760.

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 BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • WATER (UNII: 059QF0KO0R)
  • 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • 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 Co
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: 03-30-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Mucus Relief Dm And Overnight Cold And Flu Product Label Images

Mucus Relief Dm And Overnight 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

Drug Facts

Otc - Purpose

Active ingredients (in each 20 mL)Maximum Strength Mucus Relief DMPurposesDextromethorphan HBr 20 mgCough suppressantGuaifenesin 400 mgExpectorantActive ingredients (in each 20 mL)PurposesOvernight Cold & FluAcetaminophen 650 mgPain reliever/fever reducerDextromethorphan HBr 20 mgAntihistamine/cough suppressantTriprolidine HCl 2.5 mgNasal decongestant

Uses

  • MAXIMUM STRENGTH MUCUS RELIEF DM •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive •temporarily relieves •cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled imitants •the intensity of coughing •the impulse to cough to help you get to sleep

  • ▪temporarily relieves these common cold and flu symptoms:▪cough▪minor aches and pains▪sore throat▪headache▪runny nose▪sneezing▪itching of the nose or throat▪itchy, watery eyes due to hay fever▪temporarily reduces fever▪controls cough to help you get to sleep

Warnings

  • 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.

  • Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take\▪more than 4000 mg in 24 hours, which is the maximum daily amount▪with other drugs containing acetaminophen▪3 or more alcoholic drinks daily while using this product

Ask A Doctor Before Use If You Have

  • ▪persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema▪cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If

  • ▪cough lasts more than 7 days comes back or occurs with fever, rash or headache that lasts. These could be sings of a serious condition.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison control Centre right away at 1-800-222-1222

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 Centre right away at 1-800-222-1222.Quick medical attention is critical for adults as well as for children, even if you do not notice any signs

Directions

  • •do not take more than 6 doses in any 24-hour period •measure only with dosing cup provided •do not use dosing cup with other products •dose as follows or as directed by a doctor •mL = milliliter •adults and children 12 years and older: 20 mL every 4 hours •children under 12 years of age: Do not use

  • ▪do not take more than directed (see overdose warnings▪do not take more than 4 doses in any 24-hour period▪measure only with dosing cup provided▪do not use dosing cup with other products▪dose as follows or as directed by a doctor▪adults and children 12 years of age and older: 20 ml in dosing cup provided every 4 hours▪children under 12 years of age: do not use

Other Information

  • •each 20 mL contains: sodium 8 mg •low sodium •store at room temperature •do not refrigerate •dosing cup provided

  • ▪each 20 mL contains: sodium 10 mg▪low sodium▪store at room temperature▪do not refrigerate

Inactive Ingredients (Maximum Strength Mucus Relief Dm)

Anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red No. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

If Pregnant Or Breast Feeding

Ask a health professional before use

Inactive Ingredients (Overnight Cold & Flu)

Anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

* Please review the disclaimer below.