NDC 81179-803 Daytime Nighttime Cold And Flu Relief

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

NDC Product Code 81179-803

NDC CODE: 81179-803

Proprietary Name: Daytime Nighttime Cold And Flu Relief 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, Doxylamine Succinate, 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.

Product Characteristics

Color(s):
GREEN (C48329)
RED (C48326)
Shape: CAPSULE (C48336)
OVAL (C48345)
Size(s):
20 MM
Imprint(s):
IS2
IS1
Score: 1

NDC Code Structure

  • 81179 - Yet Health Group Llc
    • 81179-803 - Daytime Nighttime Cold And Flu Relief

NDC 81179-803-01

Package Description: 1 BOTTLE in 1 CARTON > 1 KIT in 1 BOTTLE * 40 CAPSULE, LIQUID FILLED in 1 BOTTLE (81179-044-01) * 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (81179-088-01)

NDC Product Information

Daytime Nighttime Cold And Flu Relief with NDC 81179-803 is a a human over the counter drug product labeled by Yet Health Group Llc. The generic name of Daytime Nighttime Cold And Flu Relief is acetaminophen, dextromethorphan hbr, doxylamine succinate, 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: 1094549, 1110988, 1546881 and 1730211.

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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE (UNII: FZ989GH94E)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • POLYETHYLENE GLYCOL 1000000 (UNII: HZ58M6D839)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SORBITAN (UNII: 6O92ICV9RU)

Product Labeler Information

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

Labeler Name: Yet Health Group Llc
Labeler Code: 81179
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: 09-02-2021 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 Relief 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

Nighttime Cold & Flu Active Ingredients (In Each Softgel)

Acetaminophen 325 mgDextromethorphan HBr 15 mgDoxylamine succinate 6.25 mg

Daytime Cold & Flu Active Ingredients (In Each Softgel)

Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Nighttime Cold & Flu Purpose

Pain reliever/fever reducerCough suppressantAntihistamine

Daytime Cold & Flu Purpose

Pain reliever/fever reducerCough suppressantNasal decongestant

Nighttime Cold & Flu Uses

  • Temporarily relieves common cold/flu symptoms:cough due to minor throat and bronchial irritationsore throatheadacheminor aches and painsfeverrunny nose and sneezing

Daytime Cold & Flu Uses

  • Temporarily relieves common cold/flu symptoms:nasal congestioncough due to minor throat and bronchial irritationheadacheminor aches and painsfeversore throat

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • More than 4 doses in 24 hours, which is the maximum daily amount for this productwith 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.

Do Not Use

  • With 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.if you have ever had an allergic reaction to this product or any of its ingredients

Nighttime Cold & Flu Ask A Doctor Before Use If You Have

  • Liver diseaseglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphasematrouble urinating due to an enlarged prostate gland

Daytime Cold & Flu Ask A Doctor Before Use If You Have

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandcough that occurs with too much phlegm (mucus)persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Nighttime Cold & Flu Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking sedatives or tranquilizerstaking the blood thinning drug warfarin

Daytime Cold & Flu Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin

Nighttime Cold & Flu When Using This Product

  • Do not exceed recommended dosageexcitability may occur, especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful when driving a motor vehicle or operating machineryalcohol, sedatives, and tranquilizers may increase drowsiness

Daytime Cold & Flu When Using This Product

Do not use more than directed.

Nighttime Cold & Flu Stop Use And Ask A Doctor If

  • Pain or cough gets worse or lasts more than 7 daysfever 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.

Daytime Cold & Flu Stop Use And Ask A Doctor If

  • You get nervous, dizzy or sleeplesspain, nasal congestion, or cough gets worse or lasts more than 7 daysfever 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.

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 (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.

Nighttime Cold & Flu Directions

  • Take only as directeddo not exceed 4 doses per 24 hrsadults & children 12 yrs & over2 softgels with water every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use

Daytime Cold & Flu Directions

Take only as directed

do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 2 softgels with water every 4 hrschildren 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use

Other Information

  • Store at room temperature

Nighttime Cold & Flu Inactive Ingredients

D&C YELLOW #10, FD&C BLUE #1, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL 70% SOLUTION, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

Daytime Cold & Flu Inactive Ingredients

FD&C RED #40, FD&C YELLOW #6, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

* Please review the disclaimer below.