NDC 11673-983 Cold And Flu Nighttime Severe

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

NDC Product Code 11673-983

NDC CODE: 11673-983

Proprietary Name: Cold And Flu Nighttime Severe 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
GREEN (C48329)
Shape: BULLET (C48335)
Size(s):
16 MM
Imprint(s):
72
Score: 1

NDC Code Structure

NDC 11673-983-08

Package Description: 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 11673-983-24

Package Description: 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Cold And Flu Nighttime Severe with NDC 11673-983 is a a human over the counter drug product labeled by Target Corp. The generic name of Cold And Flu Nighttime Severe is acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Target Corp

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.

Cold And Flu Nighttime Severe 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.

  • DOXYLAMINE SUCCINATE 6.25 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1

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.

  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • 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.
  • 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: 06-01-2020 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.

Cold And Flu Nighttime Severe Product Label Images

Cold And Flu Nighttime Severe 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 ingredients( in each softgel)Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Inactive Ingredient

FD&C Blue No. 1, gelatin, glycerin, shellac, titanium dioxide, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Otc - Purpose

PurposePain reliever/Fever reducerCough suppressantAntihistamineNasal decongestant

Indications & Usage

  • Temporarily relieves common cold/flu symptoms:nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationcough to help you sleepminor aches & painsheadachefeversore throatrunny nose & sneezingreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainage

Dosage & Administration

Directions

take only as directed - do not exceed 8 softgelsper 24 hrs - adults & children 12 yrs & over 2 Softgels with water every 4 hrs - children 4 to under 12 yrs ask a doctor - children ...
take only as directed

do not exceed 8 softgels 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

Warnings

WarningsLiver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 LiquiCaps in 24 hours, which is the maximum daily amount for this product - with other ...
Liver warningThis product contains acetaminophen. Severe liver damage may occur if you takemore than 8 Softgels in 24 hours, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks daily while using this product
Allergy Alert:acetaminophen may cause severe skin reactions. Symptoms may include:Skin reddening

Blisters

Rash
Sore throat warningIf 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 - Keep Out Of Reach Of Children

Keep out of reach of children.Overdose warningIn 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 as well as for children even if you do not notice any signs or symptoms.

* Please review the disclaimer below.