Active Ingredient (In Each Tablet)
Phenylephrine HCl 10mg
Redicare Nasal And Sinus Decongestant Tablet
FDA Label NDC 71105-272
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redicare Llc for the product Redicare Nasal And Sinus Decongestant (NDC 71105-272). 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 (in each tablet), purpose, uses:, do not use if, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 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 (1-800-222-1222) right away.
Directions:
Adults and children 12 years and over: ■ 1 tablet every 4 hours ■ do not take more than 6 tablets in 24 hours
Children under 12 years: ask a doctor
Other Information:
■ store at room temperature 20°– 25°C (68°– 77°F)
■ do not use if carton or blister unit is opened or broken [for blister]
Inactive Ingredients:
croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, Opadry Clear YS-1-7006, polyethylene glycol, propylene glycol*, silicon dioxide, titanium dioxide. *May contain this ingredient
Questions Or Comments?
Call 1-866-561-5650 Monday through Friday 9AM - 5PM
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Principal Image (Decongestant 107x86x63 08feb2025 03)
* Please review the disclaimer below.
