Valumeds Nasal Decongestant Phenylephrine Hcl Tablet
FDA Label NDC 82725-1111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Valumeds Nasal Decongestant Phenylephrine Hcl (NDC 82725-1111). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Uses
• temporarily relieves sinus congestion and pressure •temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings
Do Not Use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fordepression, 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 a 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 dose
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
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. (1-800-222-1222)
Directions
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other Information
store between 20°–25°C (68°–77°F)
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate, FD&C red no. 40, hypromellose, indigo carmine lake, magnesium stearate, methacrylic acid polymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions Or Comments?
Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00PM EST
Package Labeling:
Bottle (Bottle)
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