FDA.reportPublic FDA data

Dr. Sheffield's Original 12 Hour Relief Nasal Spray

Manufacturer
Navajo Manufacturing Company Inc. | Sheffield Pharmaceuticals LLC
Effective date
2020-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:01:44

Label at a glance#

Product12 Hour Original Nasal Decongestant
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

Tempoarily relieves nasal congestion due to: common cold hay fever sinusitis upper respiratory allergies Shrinks swollen membranes so you can breathe more freely.

Dosage and administration

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age consult a doctor To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying. Wipe nozzle clean after use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies

Shrinks swollen membranes so you can breathe more freely.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed
  • do not use for more than three days. Use only 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 than one person may spread infection.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age consult a doctor

To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying. Wipe nozzle clean after use.

Other information

OTHER SAFETY INFORMATION

  • store at a controlled room temperature 20°-25°C (68°-77°F)
  • keep card for future reference on full labeling

SPL UNCLASSIFIED SECTION

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Disodium EDTA, Disodium Phosphate, Glycerin, PEG-6, Propylene Glycol, PVP, Sodium Phosphate, Water (Purified)

Principal Dipslay Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nasal SprayNasal Spray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-140-55ML - Milliliter11527-14082b4bf48-041a-4d80-89ab-bdf904601d8712025-02-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-20967751-209-01
11527-140

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DISODIUM EDTA-COPPER6V475AX06UIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
POVIDONE K29/32390RMW2PEQIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
12 Hour Original Nasal DecongestantNASAL SPRAYSheffield Pharmaceuticals LLCcea0ce76-ae75-4484-a7c2-ff1086e9d8b02023-10-30WarningsExact identifier
ndc (product): 11527-140
ebe027b5-9d20-2d43-e053-2a95a90ad029b61ec60f-dc2b-560d-e053-2a95a90abf4e2022-10-25WarningsExact identifier
spl set id: b61ec60f-dc2b-560d-e053-2a95a90abf4e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.