Up And Up Cold Flu Relief Day Night
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Target Corporation
Human Otc Drug
NDC 11673-733Up And Up Cold Flu Relief Day Night also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Target Corporation'. National Drug Code (NDC) number for Up And Up Cold Flu Relief Day Night is 11673-733. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Up And Up Cold Flu Relief Day Night drug includes . The currest status of Up And Up Cold Flu Relief Day Night drug is Active.
Drug Information:
| Drug NDC: | 11673-733 |
| 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: | Up And Up Cold Flu Relief Day Night |
| 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 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: | 18 Aug, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 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: | 1043400
1113705
1484901
|
| 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 |
|---|
| 11673-733-02 | 1 KIT in 1 CARTON (11673-733-02) * 1 BOTTLE in 1 CARTON / 355 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 355 mL in 1 BOTTLE | 18 Aug, 2014 | 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:
Purpose - nighttime pain reliever/fever reducer cough suppressant antihistamine
Purpose - daytime pain reliever/fever reducer cough suppressant nasal decongestant
Product Elements:
Up and up cold flu relief day night acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl up and up cold and flu relief acetaminophen, dextromethorphan hbr, doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine alcohol anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 high fructose corn syrup polyethylene glycol propylene glycol water saccharin sodium sodium citrate clear/dark red menthol aroma up and up cold flu relief acetaminophen, dextromethorphan hbr, phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine butylated hydroxyanisole edetate disodium fd&c yellow no. 6 glycerin sodium phosphate, monobasic, anhydrous polyethylene glycol propylene glycol water saccharin sodium sucrose xanthan gum menthol clear with fruit
Indications and Usage:
Uses - nighttime temporarily relieves common cold/flu symptoms: ⢠cough due to minor throat and bronchial irritation ⢠sore throat ⢠headache ⢠minor aches and pains ⢠fever ⢠runny nose and sneezing
Uses - daytime temporarily relieves common cold/flu symptoms: ⢠nasal congestion ⢠cough due to minor throat and bronchial irritation ⢠sore throat ⢠headache ⢠minor aches and pains ⢠fever
Warnings:
Warnings - daytime liver warning: this product contains acetaminophen. the maximum daily dose of this product is 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. severe liver damage may occur if ⢠adult takes more than 4,000 mg of acetaminophen in 24 hours ⢠child takes more than 5 doses in 24 hours, which is the maximum daily amount ⢠taken with other drugs containing acetaminophen ⢠adult has 3 or more alcoholic drinks every day while using this product sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use - nighttime ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, ps
Read more...ychiatric, or emotional conditions, or parkinsonâs disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ⢠to make a child sleepy ⢠if you have ever had an allergic reaction to this product or any of its ingredients do not use - daytime ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ⢠if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have - nighttime ⢠liver disease ⢠trouble urinating due to an enlarged prostate gland ⢠cough that occurs with too much phlegm (mucus) ⢠persistent or chronic cough as occurs with smoking, asthma, or emphysema ⢠a breathing problem such as emphysema or chronic bronchitis ⢠glaucoma ⢠a sodium-restricted diet ask a doctor before use if you have - daytime ⢠liver disease ⢠heart disease ⢠thyroid disease ⢠diabetes ⢠high blood pressure ⢠trouble urinating due to an enlarged prostate gland ⢠cough that occurs with too much phlegm (mucus) ⢠persistent or chronic cough as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are - nighttime ⢠taking sedatives or tranquilizers ⢠taking the blood thinning drug warfarin ask a doctor or pharmacist before use if you are - daytime taking the blood thinning drug warfarin when using this product - nighttime ⢠excitability may occur, especially in children ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery ⢠alcohol, sedatives, and tranquilizers may increase drowsiness when using this product - daytime do not use more than directed stop use and ask a doctor if - nighttime ⢠pain or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. stop use and ask a doctor if - daytime ⢠you get nervous, dizzy or sleepless ⢠pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. 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 as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings - daytime liver warning: this product contains acetaminophen. the maximum daily dose of this product is 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. severe liver damage may occur if ⢠adult takes more than 4,000 mg of acetaminophen in 24 hours ⢠child takes more than 5 doses in 24 hours, which is the maximum daily amount ⢠taken with other drugs containing acetaminophen ⢠adult has 3 or more alcoholic drinks every day while using this product sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use - nighttime ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ⢠to make a child sleepy ⢠if you have ever had an allergic reaction to this product or any of its ingredients do not use - daytime ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ⢠if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have - nighttime ⢠liver disease ⢠trouble urinating due to an enlarged prostate gland ⢠cough that occurs with too much phlegm (mucus) ⢠persistent or chronic cough as occurs with smoking, asthma, or emphysema ⢠a breathing problem such as emphysema or chronic bronchitis ⢠glaucoma ⢠a sodium-restricted diet ask a doctor before use if you have - daytime ⢠liver disease ⢠heart disease ⢠thyroid disease ⢠diabetes ⢠high blood pressure ⢠trouble urinating due to an enlarged prostate gland ⢠cough that occurs with too much phlegm (mucus) ⢠persistent or chronic cough as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are - nighttime ⢠taking sedatives or tranquilizers ⢠taking the blood thinning drug warfarin ask a doctor or pharmacist before use if you are - daytime taking the blood thinning drug warfarin when using this product - nighttime ⢠excitability may occur, especially in children ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery ⢠alcohol, sedatives, and tranquilizers may increase drowsiness when using this product - daytime do not use more than directed stop use and ask a doctor if - nighttime ⢠pain or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. stop use and ask a doctor if - daytime ⢠you get nervous, dizzy or sleepless ⢠pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. 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 as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product - nighttime ⢠excitability may occur, especially in children ⢠marked drowsiness may occur ⢠avoid alcoholic drinks ⢠be careful when driving a motor vehicle or operating machinery ⢠alcohol, sedatives, and tranquilizers may increase drowsiness
When using this product - daytime do not use more than directed
Dosage and Administration:
Directions - nighttime ⢠take only as directed â see liver warning ⢠use dose cup ⢠do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 ml (2 tbsp) every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use ⢠when using other daytime or nighttime products, carefully read each label to insure correct dosing
Stop Use:
Stop use and ask a doctor if - nighttime ⢠pain or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.
Stop use and ask a doctor if - daytime ⢠you get nervous, dizzy or sleepless ⢠pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition
Package Label Principal Display Panel:
Principal display panel - daytime compare to active ingredients in vicks® dayquil® cold & flu cold/flu relief multi-symptom day / non-drowsy pain reliever/fever reducer, cough suppressant, nasal decongestant acetaminophen â aches/fever dextromethorphan hbr â cough phenylephrine hcl â nasal congestion alcohol free, antihistamine free day original flavor
Principal display panel - nighttime compare to active ingredients in vicks® nyquil® cold & flu cold/flu relief multi-symptom night antihistamine, cough suppressant, fever reducer/pain reliever acetaminophen â aches/fever/sore throat dextromethorphan hbr â cough doxylamine succinate â sneezing, runny nose does not contain pseudoephedrine alcohol 10% night cherry flavor two â 12 fl oz (355 ml), total 24 fl oz (1.5 pt) (710 ml) up and up cold/flu relief day night image 1 up & up cold/flu relief day night image 2 up & up cold/flu relief day night image 3
Further Questions:
Questions? call 1-800-910-6874