NDC 11673-969 Daytime- Nighttime Cold And Flu

Daytime Nighttime Cold And Flu

NDC Product Code 11673-969

NDC CODE: 11673-969

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: Daytime Nighttime Cold And Flu 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):
ORANGE (C48331)
GREEN (C48329)
Shape: CAPSULE (C48336)
Size(s):
20 MM
21 MM
Imprint(s):
70
71
Score: 1

NDC Code Structure

  • 11673 - Target Corp

NDC 11673-969-48

Package Description: 1 KIT in 1 BLISTER PACK * 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (11673-975-24) * 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (11673-976-24)

NDC Product Information

Daytime- Nighttime Cold And Flu with NDC 11673-969 is a a human over the counter drug product labeled by Target Corp. The generic name of Daytime- Nighttime Cold And Flu is daytime nighttime cold and flu. The product's dosage form is kit and is administered via oral form.

Labeler Name: Target Corp

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 RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SHELLAC (UNII: 46N107B71O)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SORBITOL (UNII: 506T60A25R)
  • POVIDONE (UNII: FZ989GH94E)
  • GELATIN (UNII: 2G86QN327L)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • SHELLAC (UNII: 46N107B71O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • POVIDONE (UNII: FZ989GH94E)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • GELATIN (UNII: 2G86QN327L)

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.
  • 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: Target Corp
Labeler Code: 11673
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: 07-08-2020 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 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.

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

Daytime Cold And Flu Reliefdrug Facts

DRUG FACTS

Otc - Active Ingredient

  • Active ingredients (in each softgels)Acetaminophen 325 mgDextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

  • Active ingredients (in each softgel)Acetaminophen 325 mgDextromethorphan HBr 15 mgDoxylamine succinate 6.25 mg

Inactive Ingredient

Inactive ingredientsFD&C blue 1, FD&C Yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, purified water, sorbitol sorbitan solution, titanium dioxide

FD&C red #40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, purified water, sorbitol sorbitan solution, titanium dioxide

Otc - Purpose

  • PURPOSEPain reliever/fever reducerCough suppressantNasal decongestant

  • Temporarily relieves common cold/flu symptoms:nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever

Indications & Usage

  • Uses
  • Temporarily relieves common cold/flu symptoms:
  • Nasal congestion cough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfever

  • Uses
  • Temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation - sore throat - headache - minor aches & pains - fever - runny nose & sneezing
  • Temporarily relieves common cold/flu symptoms:cough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfeverrunny nose & sneezing

Dosage & Administration

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

  • DIRECTIONtake only as directeddo not exceed 4 doses adults & children 12 yrs & over2 Softgels with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not 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 right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

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

Warnings

  • Warnings
  • Liver 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 product
  • Severe liver damage may occur if you take:more than 8 softgels in 24 hrs, 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 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.

  • Warnings
  • Liver 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 product ...
  • Liver warningThis 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 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 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.

Nightime Drug Facts

DRUG FACTS

* Please review the disclaimer below.