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| Product NDC Code | 68163-698 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Overnight cold and flu |
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| Type | Brand | ||||||
| Pharm Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 2173667 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | RARITAN PHARMACEUTICALS | ||||||
| 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 (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine
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 ▪ do not take more than directed (see Overdose warning ) ▪ 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 older: 20 mL in dosing cup provided every 4 hours ▪ children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, 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 ▪ 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
Purpose
Information about the drug product’s indications for use.Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Overnight Cold and Flu Acetaminophen, Dextromethorphan HBr, 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
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 - 180 mL Bottle Label Compare to the active ingredients in Mucinex® Nightshift Cold & Flu* NDC 68163-698-06 Overnight Cold & Flu Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Triprolidine HCl – Antihistamine Relieves: • Cough • Fever • Sore throat • Runny nose • Sneezing Nighttime relief for a Better Morning 6 FL OZ (180 mL) For Ages 12+ Tamper evident: do not use if printed seal under cap is broken or missing Maximum Strength per 4-hour dose Manufactured by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816 *This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu. DRx Choice Overnight Cold and Flu Relief
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.Drug Facts
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 ▪ liver disease ▪ glaucoma ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema or chronic bronchitis ▪ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ▪ cough that occurs with too much phlegm (mucus)
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 ▪ taking the blood thinning drug warfarin ▪ taking sedatives or tranquilizers
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 ▪ 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.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-467-2748
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 ▪ 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 fever, 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 ▪ do not use more than directed ▪ excitability may occur, especially in children ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ avoid alcoholic drinks ▪ use caution when driving a motor vehicle or operating machinery
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 ▪ each 20 mL contains: sodium 10 mg ▪ low sodium ▪ store at room temperature ▪ do not refrigerate
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 Liver warning 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 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. Do not use ▪ 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. Ask a doctor before use if you have ▪ liver disease ▪ glaucoma ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema or chronic bronchitis ▪ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ▪ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ▪ taking the blood thinning drug warfarin ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed ▪ excitability may occur, especially in children ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ avoid alcoholic drinks ▪ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ▪ 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 fever, 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. 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 Center right away. 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