Otc - Active Ingredient
Active Ingredients (in each pill)
Pseudoephedrine HCl 30 mg
Cvs Health Non-drowsy Nasal Decongestant
FDA Label NDC 53240-240
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Westport Pharmaceuticals for the product Cvs Health Non-drowsy Nasal Decongestant (NDC 53240-240). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Nasal Decongestant
Otc - 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. (1-800-222-1222)
Indications & Usage
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
- 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.
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 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.
Dosage & Administration
Directions: remove pill from sealed, plastic packaging before ingesting
swallow whole – do not crush, chew or dissolve
adults and children 12 years and over • take 2 pills every 4 to 6 hours
• do not take more than 8 pills in 24 hours
children ages 6 to under 12 years • take 1 pill every 4 to 6 hours
• do not take more than 4 pills in 24 hours
children ages under 6 years do not use this product in children
under 6 years of age
Inactive Ingredient
Inactive Ingredients croscarmellose sodium, guar gum, hydroxypropyl cellulose, lecithin,
microcrystalline cellulose, polyethylene glycol, sorbitan monooleate, vegetable oil, xanthan gum
* Please review the disclaimer below.
