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

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
• diabetes
• thyroid disease
• high blood pressure
• difficulty in urination due to enlargement of the 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 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 (1-800-222-1222) right away.

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

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0992

NDC: 50090-0992-0 36 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Phenylephrine HCl

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Products#

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

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

• Sudogest PE
• Phenylephrine HCl
• PHENYLEPHRINE HYDROCHLORIDE
• PHENYLEPHRINE
• CROSCARMELLOSE SODIUM
• DEXTROSE MONOHYDRATE
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• FD&C RED NO. 40
• MAGNESIUM STEARATE
• MALTODEXTRIN
• MICROCRYSTALLINE CELLULOSE
• TITANIUM DIOXIDE
• SILICON DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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.