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| Product NDC Code | 11822-1591 | ||||
|---|---|---|---|---|---|
| Drug Name | Day cold and flu night cold and flu |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1297288, 1656815, 2634364 |
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| Application Number | part341 | ||||
| Labeler Name | Rite Aid 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 (in each liquid gel) DAY Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Active ingredients (in each liquid gel) NIGHT Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 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 • do not take more than directed (see Overdose warning) • do not take more than 10 liquid gels in any 24-hour period • adults and children 12 years of age and older: take 2 liquid gels 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 (DAY only) edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Inactive ingredients (NIGHT only) D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
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: • sinus congestion and pressure • cough • minor aches and pains • headache • nasal congestion • sore throat • runny nose (NIGHT only) • sneezing (NIGHT only) • itching of the nose or throat (NIGHT only) • itchy, watery eyes due to hay fever (NIGHT only) • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only) • controls cough to help you get to sleep • temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purposes DAY Cold & Flu Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Purposes NIGHT Cold & Flu Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.day cold and flu night cold and flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate day cold and flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN 7G0 night cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN 345
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 COMBO PACK Compare to the active ingredients of Mucinex ® Fast-Max ® Day Cold & Flu & Mucinex ® Fast-Max ® Night Cold & Flu fast dissolving liquid gels MAXIMUM STRENGTH daytime day cold & flu acetaminophen dextromethorphan HBr guaifenesin phenylephrine HCl pain reliever/fever reducer cough suppressant expectorant nasal decongestant relieves aches, fever & sore throat controls cough relieves nasal & chest congestion thins & loosens mucus ACTUAL SIZE 16 LIQUI GELS (liquid filled capsules) MAXIMUM STRENGTH nighttime night cold & flu acetaminophen dextromethorphan HBr doxylamine succinate phenylephrine HCl pain reliever/fever reducer cough suppressant antihistamine nasal decongestant relieves aches, fever & sore throat controls cough relieves runny nose & sneezing ACTUAL SIZE 8 LIQUID GELS (liquid filled capsules) 24 TOTAL For ages 12+ day cold and flu night cold and flu image
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 • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • glaucoma (NIGHT only) • a breathing problem such as emphysema or chronic bronchitis (NIGHT only) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 (NIGHT only)
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 these products. • if you have ever had an allergic reaction to these products or any of their 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. Overdose warning: 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 or comments? 1-800-719-9260
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 • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion 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.
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 these products • do not use more than directed • excitability may occur, especially in children (NIGHT only) • marked drowsiness may occur (NIGHT only) • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only) • avoid alcoholic drinks (NIGHT only) • be careful when driving a motor vehicle or operating machinery (NIGHT only)
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 • 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 Liver warning: These products contain 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 these products 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 these products. • if you have ever had an allergic reaction to these products or any of their ingredients Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • glaucoma (NIGHT only) • a breathing problem such as emphysema or chronic bronchitis (NIGHT only) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 (NIGHT only) When using these products • do not use more than directed • excitability may occur, especially in children (NIGHT only) • marked drowsiness may occur (NIGHT only) • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only) • avoid alcoholic drinks (NIGHT only) • be careful when driving a motor vehicle or operating machinery (NIGHT only) Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion 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. If pregnant or breast-feeding, ask a health professional before use.
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