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| Product NDC Code | 11673-733 | ||||
|---|---|---|---|---|---|
| Drug Name | Up and up cold flu relief day night |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1043400, 1113705, 2637726 |
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| Application Number | part341 | ||||
| Labeler Name | Target Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients - Nighttime (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg
Active ingredients - Daytime (in each 15 mL tablespoon) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions - Nighttime • take only as directed – 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
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients - Nighttime alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Inactive Ingredients - Daytime butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose - Nighttime Pain reliever/fever reducer Cough suppressant Antihistamine
Purpose - Daytime Pain reliever/fever reducer Cough suppressant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 – aches/fever dextromethorphan HBr – cough phenylephrine HCl – 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 – aches/fever/sore throat dextromethorphan HBr – cough doxylamine succinate – sneezing, runny nose does not contain pseudoephedrine ALCOHOL 10% NIGHT cherry flavor TWO – 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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Warnings - Nighttime Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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 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.
Directions - Daytime • take only as directed – see Liver warning • use dose cup • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL (2 TBSP) every 4 hrs children 6 to under 12 yrs 15 mL (1 TBSP) every 4 hrs children 4 to under 6 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
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Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 Parkinson’s 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 Parkinson’s 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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-910-6874
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information - Nighttime • each 30 mL dose cup contains: sodium 39 mg • store at 20-25°C (68-77°F)
Other information - Daytime • each tablespoon contains: sodium 7 mg • store at 20-25°C (68-77°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Parkinson’s 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 Parkinson’s 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API