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| Product NDC Code | 76168-056 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Nighttime cold and flu |
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| Type | Brand | ||||||
| Pharm Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 | CAPSULE, LIQUID FILLED | ||||||
| RxCUI drug identifier | 1094549 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Velocity Pharma | ||||||
| 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 Ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 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.Direction do not exceed 4 doses per 24 hours take only as directed – see overdose warning Adults and children 12 years and over: 2 softgels with water every 4 hours children under 12 years: ask a doctor Children under 4 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide
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 pain reliever, cough suppressant and Antihistamine
Purpose
Information about the drug product’s indications for use.Purpose pain reliever Cough Suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.NightTime Cold and Flu Acetaminophen,Dextromethorphan,Doxylamine FD&C BLUE NO. 1 FD&C YELLOW NO. 6 GELATIN POLYETHYLENE GLYCOL 1000 POVIDONE PROPYLENE GLYCOL SORBITOL TITANIUM DIOXIDE GLYCERIN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE 215
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 76168-056-02 12 softgels 311d7647-figure-01
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.Other Information store at room temperature
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. If pregnant or breast-feeding, ask a health professional before use. Overdose warning : Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.
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 Call toll free 1-855-314-1850
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 Warnings Failure to follow these warnings could result in serious consequences. Liver Warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 4 doses in 24 hours which is maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product do not use: with any other drug containing acetaminophen (prescription or not prescription). 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 Heart disease Thyroid disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if: Redness or swelling is present You get nervous, dizzy or sleepless Fever gets worse or lasts more than 3 days New symptoms occur Symptoms do not get better within 7 days or are accompanied by a fever
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