NDC 11673-946 Night Cold And Flu Relief

Acetaminophen,

NDC Product Code 11673-946

NDC CODE: 11673-946

Proprietary Name: Night 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, 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)
Shape: OVAL (C48345)
Size(s):
16 MM
Imprint(s):
72
Score: 1

NDC Code Structure

  • 11673 - Target Corp

NDC 11673-946-08

Package Description: 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Night Cold And Flu Relief with NDC 11673-946 is a a human over the counter drug product labeled by Target Corp. The generic name of Night Cold And Flu Relief is acetaminophen, . The product's dosage form is capsule, liquid filled and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1297288.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Night Cold And Flu Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


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.

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

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: 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: 07-01-2021 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: 12-31-2021 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.

Night Cold And Flu Relief Product Label Images

Night 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

Otc - Active Ingredient

Active ingredeints in each softgelACETAMINOPHEN 325 mgDextromethorphan Hydrobromide 10 mgDoxylamine Succinate 6.25 mgPhenylephrine HCl 5 mg

Inactive Ingredient

Inactive ingredients: FD&C Blue #1,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, , sorbitol sorbitan solution, titanium dioxide

Otc - Purpose

PURPOSEPain Reliever-Fever ReducerCough SuppressantAntihistamineNasal Decongestant

Indications & Usage

INDICATIONS & USAGEUses· temporarily relieves these symptoms due to a cold or flu:· minor aches and pains · headache · cough· sore throat · nasal and sinus congestion· temporarily reduces fever

Dosage & Administration

Directions· do not take more than the recommended dose· adults and children 12 years and over: take 2 capsules with waterevery 4 hours. Do not exceed 10 capsules in 24 hours or asdirected by a doctor.· children under 12 years: do 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings

WarningsLiver 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 acetaminophen· 3 or more aloholic drinks every day while using this productl Allergy alert: Acetaminophen may cause severe skin or severeallergic reactions. Symptoms may include:· skin reddening · blisters · rash · hives· facial swelling · asthma (wheezing) · shockIf a skin or general allergic reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than2 days, is accompanied or followed by fever, headache, rash, nausea,or vomiting, consult a doctor promptly.

* Please review the disclaimer below.