NDC 0363-0729 Daytime Nighttime Cold And Flu

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl And Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

NDC Product Code 0363-0729

NDC CODE: 0363-0729

Proprietary Name: Daytime Nighttime 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, Dextromethorphan Hbr, Phenylephrine Hcl And Acetaminophen, Dextromethorphan Hbr, 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.

Product Characteristics

Color(s):
GREEN (C48329)
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
21 MM
Imprint(s):
71
70
Score: 1

NDC Code Structure

  • 0363 - Walgreens

NDC 0363-0729-24

Package Description: 2 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0363-0850-08) * 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0363-0853-16)

NDC Product Information

Daytime Nighttime Cold And Flu with NDC 0363-0729 is a a human over the counter drug product labeled by Walgreens. The generic name of Daytime Nighttime Cold And Flu is acetaminophen, dextromethorphan hbr, phenylephrine hcl and acetaminophen, dextromethorphan hbr, doxylamine succinate. The product's dosage form is kit and is administered via oral form.

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)
  • GELATIN (UNII: 2G86QN327L)
  • POVIDONE (UNII: FZ989GH94E)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SHELLAC (UNII: 46N107B71O)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITAN (UNII: 6O92ICV9RU)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SORBITAN (UNII: 6O92ICV9RU)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SHELLAC (UNII: 46N107B71O)
  • WATER (UNII: 059QF0KO0R)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

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: 10-15-2021 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.

Daytime Nighttime Cold And Flu Product Label Images

Daytime Nighttime 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

Otc - Active Ingredient

Daytime Cold & Flu
Active ingredients (in each softgel)
Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg
Nighttime Cold & Flu
Active ingredients (in each softgel)
Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Otc - Purpose

Daytime Cold & Flu
Purpose
Pain reliever/fever reducer

Cough suppressant

Nasal decongestant
Nighttime Cold & Flu
Purpose
Pain reliever/fever reducer

Cough suppressant

Antihistamine

Indications & Usage

  • Uses
  • Temporarily relieves common cold/flu symptoms:
  • Nasal congestion (Daytime only)cough due to minor throat and bronchial irritationsore throatheadacheaches and painsfeverrunny nose and sneezing (Nighttime only)

Warnings

  • WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • More than 8 softgels in 24 hrs, which is the maximum daily amount for this productwilh other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: 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.

Otc - Do Not Use

  • Do not usewith 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.

Otc - Ask Doctor

  • Ask a doctor before use if you haveliver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to enlarged prostate glandcough that occurs with too much phlegm (mucus)glaucoma (Nighttime only)a breathing problems or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis, or emphysema (Nighttime only)persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarintaking sedatives or tranquilizers (Nighttime only)

Otc - When Using

  • When using this productdo not use more than directedexcitability may occur, especially in children
  • (Nighttime only)marked drowsiness may occur
  • (Nighttime only)alcohol, sedatives, and tranquilizers may increase drowsiness
  • (Nighttime only)avoid alcoholic drinks
  • (Nighttime only)be careful when driving a motor vehicle or operating machinery
  • (Nighttime only)

Otc - Stop Use

  • Stop use and ask a doctor Ifyou get nervous, dizzy or sleeplesspain, nasal congestion or cough get worse or last more than 7daysfever 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.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionstake only as directeddo not exceed 4 doses per 24 hrsadults & children 12yrs & over: 2 softgels with water every 6 hrs(Nighttime only)
  • 2 softgels with water every 6 hrs (Daytime only)
  • Children 4 to under12 yrs: ask a doctor
  • Children under 4 yrs: do not use

Other Information

  • Other informationstore at room temperature

Inactive Ingredient

Inactive ingredients (Daytime only)

FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Inactive ingredients (Nighttime only)

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Otc - Questions

Questions? Call 1-877-290-4008

* Please review the disclaimer below.