FDA.reportPublic FDA data

Nasal Decongestant

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2022-11-28
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:46:17

Label at a glance#

ProductNasal Decongestant
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

■ temporarily relieves sinus congestion and pressure ■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and administration

 adults and children 12 years and over  ■ take 1 tablet every 4 hours ■ do not take more than 6 tablets in 24 hours  children under 12 years  ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves sinus congestion and pressure
■ temporarily relieves nasal congestion due to the common cold, hay
fever or other upper respiratory allergies

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ nervousness, dizziness, or sleeplessness occur
■ symptoms do not improve within 7 days or occur with a fever

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or
contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 12 years
and over 		 ■ take 1 tablet every 4 hours
■ do not take more than 6 tablets in
24 hours
 children under 12 years ask a doctor

Other information

OTHER SAFETY INFORMATION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrytalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, titanium dioxide
*contains one or more of these ingredients

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT IN

SUDAFED® PE CONGESTION®†

MAXIMUM STRENGTH

Nasal Decongestant

· Phenylephrine HCl 10 mg - Nasal Decongestant

Relieves Nasal & Sinus Congestion,
Reduces Sinus Pressure, Non-Drowsy

Actual Size

PSEUDOEPHEDRINE FREE

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Sudafed PE® Congestion

image descriptionimage description

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-110868210-1108-2, 68210-1108-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c01f5da-3e34-b7e3-e063-6294a90ac06a3dca2dfa-3745-4f38-822b-abaf37b2d00b2023-12-08WarningsExact identifier
spl set id: 3dca2dfa-3745-4f38-822b-abaf37b2d00b

Reported adverse events (FAERS/openFDA)#

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