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Drug Facts
Nasal And Sinus Decongestant Tablet
FDA Label NDC 73598-1264
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jhk Inc Dba American Safety & First Aid for the product Nasal And Sinus Decongestant (NDC 73598-1264). 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 other, active ingredient (in each tablets), purpose, use, otc - do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablets)
Phenylephrine HCl 5 mg
Purpose
nasal decongestant
Use
temporarily relieves nasal congestion due to:
- common cold
- hay fever or other upper respiratory allergies
Otc - Do Not Use
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 an MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Otc - When Using
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 are accompanied by fever
- new symptoms occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a health professional before use.
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.
Directions
- Adults and children 12 years of age and older take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
- Children under 12 years of age: ask a doctor
Other Information
- do not use if packet is opened or torn
- store at room temperature, 59° - 86°F (15° - 30°C)
- avoid excessive heat and humidity
Inactive Ingredients
croscarmellose sodium, D&C Red #27, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid
Questions?
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8:00am-5:00pm EST
Principal Display Panel - 100 Tablet Box
Product #1262
Nasal & Sinus
Decongestant II
Nasal Decongestant
Active ingredient:
Phenylephrine
- Helps reduce nasal and sinus congestion and
pressure, and helps restore free breathing
through the nose
These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.
100 Tablets • 2 Tablets Per Packet
Principal Display Panel (100 Tablet Box)
Principal Display Panel - 250 Tablet Box
Product #1264
Nasal & Sinus
Decongestant II
Nasal Decongestant
Active ingredient:
Phenylephrine
- Helps reduce nasal and sinus congestion and
pressure, and helps restore free breathing
through the nose
These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.
250 Tablets • 2 Tablets Per Packet
Principal Display Panel (250 Tablet Box)
* Please review the disclaimer below.
