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| Product NDC Code | 47682-809 | ||||||||||||
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| Drug Name | Medi-first sinus decongestant |
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| Type | Brand | ||||||||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||||||
| Application Number | M012 | ||||||||||||
| Labeler Name | Unifirst First 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.Drug Facts Active ingredient (in each tablet) Phenylephrine HCl 10 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 use more than directed Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses in 24 hours. Children under 12 years: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, 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 ■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ sinus congestion and pressure
Purpose
Information about the drug product’s indications for use.Purpose Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Medi-First Sinus Decongestant PHENYLEPHRINE HYDROCHLORIDE CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE red ROUND 272 Medi-First Plus Sinus Decongestant PHENYLEPHRINE HYDROCHLORIDE CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE red ROUND 272
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.Medi-First Sinus Decongestant Label 100 Tablets (100 x 1) Medi-First® Sinus Decongestant Compare active ingredients to: Sudafed® PE Registered Trademark of Pfizer Consumer Nasal Decongestant ● Phenylephrine HCl 10mg Tamper Evident Unit Dose Packets MF Sinus
Medi-First Plus Sinus Decongestant Label 100 Tablets (100 x 1's) Medi-First® Plus Sinus Decongestant Phenylephrine HCl 10mg Pull To Open Pseudoephedrine Free Sinus Relief Compare active ingredient to: Sudafed PE® Registered Trademark of McNeil Consumer Healthcare Tamper Evident Unit Dose Packets MFP Sinus
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 59º-86º F (15º-30º C) tamper evident sealed packets do not use any opened or torn packets
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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland
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 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.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever
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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, ask a health professional before use.
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 Do not use 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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