NDC 0363-5480 Multi Symptom Severe Cold And Nighttime Severe Cold And Cough

Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Phenylephrine Hcl

NDC Product Code 0363-5480

NDC CODE: 0363-5480

Proprietary Name: Multi Symptom Severe Cold And Nighttime Severe Cold And Cough 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, 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 - Walgreen Co.
    • 0363-5480 - Multi Symptom Severe Cold And Nighttime Severe Cold And Cough

NDC 0363-5480-12

Package Description: 1 KIT in 1 CARTON * 6 PACKET in 1 CARTON > 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON > 1 POWDER, FOR SOLUTION in 1 PACKET

NDC Product Information

Multi Symptom Severe Cold And Nighttime Severe Cold And Cough with NDC 0363-5480 is a a human over the counter drug product labeled by Walgreen Co.. The generic name of Multi Symptom Severe Cold And Nighttime Severe Cold And Cough is acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine 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: 1189316, 1659960 and 1804449.

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)
  • CARAMEL (UNII: T9D99G2B1R)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUCROSE (UNII: C151H8M554)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUCROSE (UNII: C151H8M554)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Labeler Information

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

Labeler Name: Walgreen 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: 06-22-2018 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: 12-31-2022 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.

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]
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.

Multi Symptom Severe Cold And Nighttime Severe Cold And Cough 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 (In Each Packet) – Multi Symptom Severe Cold

Acetaminophen 500 mgDextromethorphan hydrobromide 20 mgPhenylephrine hydrochloride 10 mg

Active Ingredients (In Each Packet) - Nighttime Severe Cold And Cough

Acetaminophen 650 mgDiphenhydramine hydrochloride 25 mgPhenylephrine hydrochloride 10 mg

Purpose - Multi Symptom Severe Cold

Pain reliever/fever reducerCough SuppressantNasal Decongestant

Purpose - Nighttime Severe Cold And Cough

Pain reliever/fever reducerAntihistamine/Cough suppressantNasal decongestant

Uses - Multi Symptom Severe Cold

  • •temporarily relieves these symptoms due to a cold: •minor aches and pains •minor sore throat pain •headache •nasal and sinus congestion •cough due to minor throat and bronchial irritation •temporarily reduces fever

Uses - Nighttime Severe Cold And Cough

  • •temporarily relieves these symptoms due to a cold: •minor aches and pains •minor sore throat pain •headache •nasal and sinus congestion •runny nose •sneezing •itchy nose or throat •itchy, watery eyes due to hay fever •cough due to minor throat and bronchial irritation •temporarily reduces fever

Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold And Cough

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 4,000 mg of acetaminophen in 24 hours •with 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 reddening •blisters •rashIf 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 - Multi Symptom Severe Cold

  • •in a child under 12 years of age •if you are allergic to acetaminophen •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.

Do Not Use - Nighttime Severe Cold And Cough

  • •in a child under 12 years of age •if you are allergic to acetaminophen •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist. •with any other product containing diphenhydramine, even one used on 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.

Ask A Doctor Before Use If You Have - Multi Symptom Severe Cold

  • •liver disease •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •cough that occurs with too much phlegm (mucus) •cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask A Doctor Before Use If You Have - Nighttime Severe Cold And Cough

  • •liver 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 •cough that occurs with too much phlegm (mucus) •cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are - Multi Symptom Severe Cold

Taking the blood thinning drug warfarin

Ask A Doctor Or Pharmacist Before Use If You Are - Nighttime Severe Cold And Cough

  • •taking sedatives or tranquilizers •taking the blood thinning drug warfarin

When Using This Product - Multi Symptom Severe Cold

Do not exceed recommended dosage

When Using This Product - Nighttime Severe Cold And Cough

  • •do not exceed recommended dosage •avoid alcoholic drinks •marked drowsiness may occur •alcohol, sedatives, and tranquilizers may increase drowsiness •be careful when driving a motor vehicle or operating machinery •excitability may occur, especially in children

Stop Use And Ask A Doctor If – Multi Symptom Severe Cold /Nighttime Severe Cold And Cough

  • •nervousness, dizziness, or sleeplessness occurs •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •pain, cough or nasal congestion gets worse or lasts more than 7 days •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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions – Multi Symptom Severe Cold

  • •do not use more than directed •take every 4 hours, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctorAgeDoseAdults and children 12 years of age One packetChildren under 12 years of ageDo not use •dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. •if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat

Directions Nighttime Severe Cold And Cough

  • •do not use more than directed •take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctorAgeDoseAdults and Children 12 years of age and overOne packetChildren under 12 years of agedo not use •dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. •if 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 - Multi Symptom Severe Cold

  • •each packet contains: potassium 6 mg •store at room temperature. Protect from excessive heat and moisture.

Other Information - Nighttime Severe Cold And Cough

  • •each packet contains: potassium 6 mg •store at room temperature. Protect from excessive heat and moisture

Inactive Ingredients - Multi Symptom Severe Cold

Citric acid, caramel, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose

Inactive Ingredients - Nighttime Severe Cold And Cough

Citric acid, F D & C yellow #6 , flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose,

* Please review the disclaimer below.