12 Hour Original Nasal Decongestant Liquid
FDA Label NDC 11527-140

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product 12 Hour Original Nasal Decongestant (NDC 11527-140). 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 drug facts, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of the reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiroty allergies
  • Shribnk swollen membranes so you can breathemore freely

Ask A Doctor Before Use If You Have

  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

When Using This Product

  • Do not use more than directed
  • do not use for more than three days, Use onyl as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning ,stinging, sneezing or an increase in nasal discharge may occur.
  • use of this container by more thna one person may spread infection.

Stop Use And Ask A Doctor If

symptoms persist.

Keep Out Of The Reach Of Children

if swallowed, get medical help or contact a Poison Control Center right away.

Other Information

  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling

Principal Display Panel- Bottle

Lee

Relieves Conmgestion

Nasal Spray original 12 hour relief

Oxymetazoline HCL Nasal SolutionNasal Decongestant

1 FL OZ (30 ml)

Principal Display Panel -Carton

Lee

Relieves Conmgestion

Nasal Spray  original 12 hour relief

  • Oxymetazoline HCL Nasal Solution
  • Nasal Decongestant

    • 1 FL OZ (30 ml)

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