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| Product NDC Code | 76162-732 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Nighttime cold and flu max softgels maximum strength |
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| Type | Brand | ||||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||||||
| RxCUI drug identifier | 1297288 | ||||||||
| Application Number | M012 | ||||||||
| Labeler Name | TOPCO ASSOCIATES LLC | ||||||||
| 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 softgel) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Doxylamine succinate 6.25 mg Phenylephrine hydrochloride 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 • do not take more than the recommended dose • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor. • children under 12 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C yellow #6, gelatin, glycerin, pearlin silver, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, 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 • temporarily relieves these symptoms due to a cold or flu: • minor aches and pains • headache • cough • sore throat • nasal and sinus congestion • temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.NIGHTTIME Cold and Flu Max Softgels MAXIMUM STRENGTH Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride FD&C BLUE NO. 1 FD&C YELLOW NO. 6 GELATIN GLYCERIN POTASSIUM ALUMINUM DISILICATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL SORBITOL TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE (oblong) 106
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.Carton TopCare health NDC 36800-732-24 COMPARE TO ALKA-SELTZER® PLUS® MAXIMUM STRENGTH NIGHTTIME COLD & FLU POWERMAXTM GELS ACTIVE INGREDIENTS NIGHTTIME Cold & Flu Max Softgels MAXIMUM STRENGTH PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr ANTIHISTAMINE - DOXYLAMINE SUCCINATE NASAL DECONGESTANT - PHENYLEPHRINE HCl RELIEVES: • Nasal Congestion • Cough • Headache & Body Ache • Sore Throat • Runny Nose •Smaller Capsule •Same Strength 24SOFTGELS** **Liquid-Filled Capsules Carton Carton
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 n heart disease n high blood pressure • thyroid disease n diabetes • cough with excessive phlegm (mucus) • difficulty in urination due to enlargement of the prostate gland • persistent or chronic cough such 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 • 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. • if you have ever had an allergic reaction to this product or any of its ingredients • in children under 12 years of age
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. 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 or comments? 1-888-423-0139
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, cough, or nasal congestion 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. • nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use.
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 exceed recommended dosage • may cause marked drowsiness n avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • n excitability may occur, especially in children
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at room temperature. Avoid temperatures above 25°C (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 Liver warning: This product contains acetaminophen. 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 Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: • skin reddening • blisters • rash n hives • facial swelling • asthma (wheezing) • shock If a skin or general allergic 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 to sedate children. 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. • if you have ever had an allergic reaction to this product or any of its ingredients • in children under 12 years of age Ask a doctor before use if you have • liver disease n heart disease n high blood pressure • thyroid disease n diabetes • cough with excessive phlegm (mucus) • difficulty in urination due to enlargement of the prostate gland • persistent or chronic cough such as occurs with smoking, asthma, or emphysema 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 exceed recommended dosage • may cause marked drowsiness n avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • n excitability may occur, especially in children Stop use and ask a doctor if • pain, cough, or nasal congestion 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. • nervousness, dizziness, or sleeplessness occurs 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. 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