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Product NDC Code | 50332-0126 | ||||||||
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Drug Name | Sudo-tab pe |
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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 | ||||||||
RxCUI drug identifier | 1299145, 1358843 |
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Application Number | part341 | ||||||||
Labeler Name | HART Health | ||||||||
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 Ingredien t (in each tablet): Phenylephrine HCl 5mg
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 Adults and children 12 years of age and over: take 2 tablets every 4 hours while symptoms persist do not take more than 12 tablets in 24 hours unless directed by a doctor Children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide. May contain propylene glycol.
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 and sinus pressure due to the common cold hay fever upper respiratory allergies
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.Sudo-Tab PE phenylephrine hcl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL SILICON DIOXIDE TITANIUM DIOXIDE 271
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.SudoTabPE.jpg
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), for 2 weeks after stopping the MAOI drug, or if you do not know if your prescription drug contains and MAOI.
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. 1-800-222-1222
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ tablets enclosed in a sealed packet ■ do not use if packet is torn, cut or open ■ store at 59° to 86°F (15°-30°C) ■ avoid excessive heat and humidity
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 symptoms are accompanied by a fever
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:
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