Target Maximum Strength Cold Flu And Sore Throat Overnight Cold And Flu
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl And Triprolidine Hcl
Target Corporation
Human Otc Drug
NDC 11673-691Target Maximum Strength Cold Flu And Sore Throat Overnight Cold And Flu also known as Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl And Triprolidine Hcl is a human otc drug labeled by 'Target Corporation'. National Drug Code (NDC) number for Target Maximum Strength Cold Flu And Sore Throat Overnight Cold And Flu is 11673-691. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Target Maximum Strength Cold Flu And Sore Throat Overnight Cold And Flu drug includes . The currest status of Target Maximum Strength Cold Flu And Sore Throat Overnight Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 11673-691 |
| 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: | Target Maximum Strength Cold Flu And Sore Throat Overnight Cold And Flu |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Target Maximum Strength Cold Flu And Sore Throat |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Overnight Cold and Flu |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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, Guaifenesin, Phenylephrine Hcl And Triprolidine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Target Corporation |
| 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: | 30 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| 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 CORPORATION
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1116572
2173667
2289246
|
| 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 |
|---|
| 11673-691-12 | 1 KIT in 1 CARTON (11673-691-12) * 180 mL in 1 BOTTLE * 180 mL in 1 BOTTLE | 30 Mar, 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:
Active ingredients (in each 20 ml) maximum strength â¡ cold, flu & sore throat purposes acetaminophen 650 mg dextromethorphan hbr 20 mg pain reliever/fever reducer cough suppressant guaifenesin 400 mg phenylephrine hcl 10 mg expectorant nasal decongestant active ingredients (in each 20 ml) purposes maximum strength overnight cold & flu acetaminophen 650 mg pain reliever/fever reducer dextromethorphan hbr 20 mg triprolidine hcl 2.5 mg cough suppressant antihistamine
Product Elements:
Target maximum strength cold flu and sore throat overnight cold and flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl and triprolidine hcl maximum strength cold flu and sore throat acetaminophen, dextromethorphan hbr, guaifenesin and phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 potassium citrate propylene glycol propyl gallate water sodium benzoate sorbitol sucralose xanthan gum target overnight cold and flu acetaminophen, dextromethorphan hbr, phenylephrine hcl and triprolidine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan triprolidine hydrochloride triprolidine anhydrous citric acid ascorbic acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin propyl gallate propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucralose xanthan gum
Indications and Usage:
Uses maximum strength cold, flu & sore throat ⪠temporarily relieves these common cold and flu symptoms: ⪠cough ⪠nasal congestion ⪠minor aches and pains ⪠sore throat ⪠headache ⪠stuffy nose ⪠sinus congestion and pressure ⪠temporarily reduces fever ⪠temporarily promotes nasal and for sinus drainage ⪠helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Uses (overnight cold & flu ⪠temporarily relieves these common cold and flu symptoms: ⪠cough ⪠minor aches and pains ⪠sore throat ⪠headache ⪠runny nose ⪠sneezing ⪠itching of the nose or throat ⪠itchy, watery eyes due to hay fever ⪠temporarily reduces fever ⪠controls cough to help you get to sleep
Warnings:
Warnings liver warnings: this product contains acetaminophen. severe liver damage may occur if you take: ⪠more than6 doses in 24 hours which is the maximum daily amount ⪠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. if a skin reaction occurs, stop use and seek medical help right away. sore throat warnings: 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 warnings: this product contains acetaminophen. severe liver damage may occur if you take: ⪠more than 4000 mg in 24 hours, which is the maximum daily amount ⪠with other drugs containing acetaminophen ⪠3 or more alcoholic drinks daily while using this product if pregnant or breast feeding ask a health professional before use keep out of reach of children overdose warning: taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control centre right away at 1-800-222-1222. quick medical attention is critical for adults as well as for children, even if you do not notice any signs directions ⪠do not take more than directed (see overdose warnings ⪠do not take more than 4 doses in any 24-hour period ⪠measure only with dosing cup provided ⪠do not use dosing cup with other products ⪠dose as follows or as directed by a doctor ⪠adults and children 12 years
Read more... of age and over: 20 ml in dosing cup provided every 4 hours ⪠children under 12 years of age: do not use other information ⪠each 20 ml contains: sodium 10 mg ⪠low sodium ⪠store at room temperature ⪠do not refrigerate
Do Not Use:
Warnings liver warnings: this product contains acetaminophen. severe liver damage may occur if you take: ⪠more than6 doses in 24 hours which is the maximum daily amount ⪠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. if a skin reaction occurs, stop use and seek medical help right away. sore throat warnings: 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 warnings: this product contains acetaminophen. severe liver damage may occur if you take: ⪠more than 4000 mg in 24 hours, which is the maximum daily amount ⪠with other drugs containing acetaminophen ⪠3 or more alcoholic drinks daily while using this product if pregnant or breast feeding ask a health professional before use keep out of reach of children overdose warning: taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control centre right away at 1-800-222-1222. quick medical attention is critical for adults as well as for children, even if you do not notice any signs directions ⪠do not take more than directed (see overdose warnings ⪠do not take more than 4 doses in any 24-hour period ⪠measure only with dosing cup provided ⪠do not use dosing cup with other products ⪠dose as follows or as directed by a doctor ⪠adults and children 12 years of age and over: 20 ml in dosing cup provided every 4 hours ⪠children under 12 years of age: do not use other information ⪠each 20 ml contains: sodium 10 mg ⪠low sodium ⪠store at room temperature ⪠do not refrigerate
Dosage and Administration:
Directions ⪠do not take more than directed (see overdose warning) ⪠do not take more than 6 doses in any 24- hour period ⪠measure only with dosing cup provided ⪠do not use dosing cup with other products ⪠dose as follows or as directed by a doctor ⪠ml = milliliter ⪠adults and children 12 years of age and over: 20 ml in dosing cup provided every 4 hours ⪠children under 12 years of age: do not use
Directions ⪠do not take more than directed (see overdose warnings ⪠do not take more than 4 doses in any 24-hour period ⪠measure only with dosing cup provided ⪠do not use dosing cup with other products ⪠dose as follows or as directed by a doctor ⪠adults and children 12 years of age and over: 20 ml in dosing cup provided every 4 hours ⪠children under 12 years of age: do not use other information ⪠each 20 ml contains: sodium 10 mg ⪠low sodium ⪠store at room temperature ⪠do not refrigerate
Overdosage:
Overdose warnings. taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. quick medical attention is critical for adults as well as for children even if you donât notice any signs or symptoms.
Package Label Principal Display Panel:
Principal display panel - kit carton value pack ndc 11673-691-12 compare to active ingredients maximum strength ⡠mucinex® fast max® cold, flu and sore throat maximum strength ⡠cold, flu and sore throat acetaminophen ⢠pain reliever/fever reducer dextromethorphan hbr ⢠cough suppressant guaifenesin ⢠expectorant phenylephrine hcl ⢠nasal decongestant ⢠controls cough, thins & loosens mucus ⢠nasal & chest congestion ⢠sinus pressure & congestion ⢠body pain, headache, fever & sore throat *per 4-hour dose for ages 12+ 6 fl. oz. (180 ml) *this product is not manufactured or distributed by reckitt benckiser, the distributor of maximum strength mucinex® fast-max® cold, flu & sore throat. compare to mucinex® nightshift cold, flu & sore throat active ingredients** overnight cold & flu acetaminophen ⢠pain reliever/fever reducer dextromethorphan hbr ⢠cough suppressant triprolidine hcl ⢠antihistamine night time relief for a better morning maximum strength per 4-hour dose ⢠cough ⢠fever ⢠sore throat ⢠runny nose ⢠sneezing for ages 12+ 6 fl oz (180 ml) **this product is not manufactured or distributed by rb health, the distributor of mucinex® nightshift cold & flu. tamper evident: do not use if printed inner seal under cap is broken or missing. see bottle for full labeling distributed by: 094 14 8715 r00 c-001227-01-055 dist. by target corp. mpls., mn 55403 tm & © 2020 target brands, inc. questions? cal 1-866-467-2748 do not take maximum strength cold, flu & sore throat & overnight cold & flu liquids at the same time. target max strength value pack cold and flu relief
Further Questions:
Questions or comments? (1-866-467-2748)