Otc - Active Ingredient
Active Ingredient.............................Purpose
(in each tablet)
Phenylephrine HCl (5 mg)............................Nasal Decongestant
Help I Have A Stuffy Nose
FDA Label NDC 49260-716
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Help Remedies, Inc. for the product Help I Have A Stuffy Nose (NDC 49260-716). 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, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses Temporarily relieves nasal congestion due to: • the common cold• hay fever or other upper respiratory allergies• helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
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 i your prescription drug contains an
MAOI, ask a doctor of 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.
Stop use and ask a doctor if
• you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are
accompanied by fever.
Otc - Do Not Use
When using this product do not use more than directed
Otc - Keep Out Of Reach Of Children
Keep out of reach of chidlren.
In case of accidental oversode, contact a doctor or Poison Control Center immediately.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Dosage & Administration
Directions
• adults and children 12 years of age and over: 2 tablets (10 mg) every 4 hours. • do not exceed 12 tablets (60 mg) in 24 hours
• children under 12 years of age: Consult a doctor
Indications & Usage
• store at room temperature 15-30 degrees C (59-86 degrees F) in a dry place • do not use if blister package is torn.• keep container. They contain important information.
Inactive Ingredient
Inactive Ingredients
microcrystalline cellulose, magnesium stearate, silicon dioxide, dicalcium phosphate, starch, stearic acid, croscarmellose sodium
Otc - Questions
57 W. 28th St. Fl. 4
New York, NY 10001
www.helpineedhelp.com
Package Label.Principal Display Panel
Stuffylabel (Stuffynose)
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