Cold And Flu Daytime-nighttime
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Target Corp
Human Otc Drug
NDC 11673-984Cold And Flu Daytime-nighttime also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Target Corp'. National Drug Code (NDC) number for Cold And Flu Daytime-nighttime is 11673-984. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Cold And Flu Daytime-nighttime drug includes . The currest status of Cold And Flu Daytime-nighttime drug is Active.
Drug Information:
| Drug NDC: | 11673-984 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cold And Flu Daytime-nighttime |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Target Corp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 03 Jun, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | TARGET CORP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1297288
1656815
1657147
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 11673-984-24 | 24 BLISTER PACK in 1 CARTON (11673-984-24) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 03 Jun, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Pain reliever-fever reducer cough suppresent minor aches and pains chest congestion
Minor aches and pains, fever nasal congestion and sinus pressure sneezing, runny nose cough
Minor aches & pains nasal/sinus congestion & sinus pressure sneezing, runny nose cough
Product Elements:
Cold and flu daytime-nighttime acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl cold and flu daytime severe acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl phenylephrine hydrochloride phenylephrine dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin glycerin acetaminophen acetaminophen gelatin shellac sorbitol polyethylene glycol 400 propylene glycol titanium dioxide fd&c blue no. 1 fd&c red no. 40 water povidone 73 cold and flu nighttime severe acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl gelatin shellac povidone titanium dioxide fd&c blue no. 1 propylene glycol doxylamine succinate doxylamine water polyethylene glycol, unspecified glycerin sorbitol acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine dextromethorphan hydrobromide dextromethorphan 72
Indications and Usage:
Temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Purpose pain reliever/fever reducer cough suppressant antihistamine nasal decongestant minor aches and pains, fever nasal congestion and sinus pressure sneezing, runny nose cough
Warnings:
Warnings liver warning - this product contains acetaminophen. severe liver damage may occur if you take - more than 8sogtgels this product contains acetaminophen. severe liver damage may occur if you take more than 8 liquicaps in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if 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.
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 - with other ... 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 with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if 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.
Dosage and Administration:
Directions take only as directed - do not exceed 8 softgels per 24 hrs - adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Directions take only as directed - do not exceed 8 softgels per 24 hours - adults & children 12 yrs & over 2 softgels with water every 6 hrs - children 4 to under 12 yrs ask a doctor - children under 4 yrs do not use
Package Label Principal Display Panel:
Combo severe