Active Ingredient
In each tablet Pseudoephedrine HCl 30 mg
Sudogest
FDA Label NDC 50090-1955
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Sudogest (NDC 50090-1955). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, indications and usage, warnings, dosage and administration, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal Decongestant
Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Indications And Usage
INDICATIONS AND USAGE:
Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis
Temporarily relieves sinus congestion and pressure
Warnings
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.
Dosage And Administration
DOSAGE AND ADMINISTRATION:
Directions – take every 4-6 hours -Do not take more than 4 does in 24 hours
Adults and children 12 years and over – 2 tablets
Children 6 to under 12 years – 1 tablet
Children under 6 years – do not use
Inactive Ingredients
INACTIVE INGREDIENTS: acacia, calcium sulfate, carnauba Wax. colloidal silicon dioxide, corn starch, D-C red no. 27, D-C yellow no.10, FD-C red no.40, FD-C yellow no 6, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre) Kaolin, microcrystalline cellulose, polyethylene glycol (PEG) 400, , pregelatinized starch, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
Questions Or Comments?
1-800-616-2471
Storage
Store at 25°C (77°F). Excursions permitted between 15°-30°C (59°-86°F).
Protect from light.
How Supplied
Product: 50090-1955
NDC: 50090-1955-0 28 TABLET, COATED in a BOTTLE
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