Otc - Active Ingredient
Phenylephrine HCl 10mg
Non-drowsy Nasal Decongestant Pe
FDA Label NDC 70692-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Non-drowsy Nasal Decongestant Pe (NDC 70692-100). 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, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, otc - purpose, 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
Inactive Ingredient
microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10
Dosage & Administration
* take with a full glass of water
* swallow whole; do not crush, chew or dissolve
| adults and children 12 years and over |
|
| children under 12 years | Ask a doctor |
Indications & Usage
* 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 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
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
*When using this product do not exceed recommended dose.
*Stop use and ask a doctor if
*If pregnant or breast-feeding, ask a health professional before use.
*Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Otc - Keep Out Of Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Otc - Purpose
Nasal Decongestant
Package Label.Principal Display Panel
100 (100)
* Please review the disclaimer below.
