smart sense sinus pe

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

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

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

STORAGE AND HANDLING SECTION

• store at 20-25^°C (68-77^°F)
• do not use if blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT IN SUDAFED PE® CONGESTION TABLETS

ACTUAL SIZE

non-drowsy

sinus PE

PHENYLEPHRINE HYDROCHLORIDE TABLETS, 10 mg

NASAL DECONGESTANT

MAXIMUM STRENGTH

RELIEVES:

SINUS PRESSURE – CONGESTION

1 PILL / DOSE

72 TABLETS

10 mg EACH

Products#

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

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

• smart sense sinus pe
• Phenylephrine Hydrochloride
• PHENYLEPHRINE
• CARNAUBA WAX
• ANHYDROUS DIBASIC CALCIUM PHOSPHATE
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLYETHYLENE GLYCOLS
• POLYVINYL ALCOHOL
• SILICON DIOXIDE
• TALC
• TITANIUM DIOXIDE
• FD&C RED NO. 40

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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