SudoGest

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl USP, 120 mg

PURPOSE

OTC - PURPOSE SECTION

Nasal decongestant

USES

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respiratory allergies
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• temporarily relieves sinus congestion and pressure

WARNINGS

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are 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
• diabetes
• thyroid disease
• trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

• do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

• symptoms do not get better within 7 days or occur with a fever
• you get nervous, dizzy, or sleepless

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• store at 59° to 77° F in a dry place
• protect from light
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

LIVONIA, MI 48150, USA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR^®

NDC 0904-5803-15

SudoGest 12 HOUR

Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 120 mg

LONG-ACTING NASAL DECONGESTANT

RELIEVES:

• NASAL & SINUS CONGESTION DUE TO COLDS & ALLERGIES
• SINUS PRESSURE

MAXIMUM STRENGTH

NON-DROWSY

10 COATED CAPLETS^*

(120 mg EACH)

^*Capsule-Shaped Tablets

COMPARE TO the active ingredient of SUDAFED^®12 HOUR^**

^**This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark SUDAFED^®12 Hour.

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

• SudoGest
• Pseudoephedrine Hydrochloride
• PSEUDOEPHEDRINE
• CASTOR OIL
• SILICON DIOXIDE
• HYPROMELLOSE, UNSPECIFIED
• MICROCRYSTALLINE CELLULOSE
• MAGNESIUM STEARATE
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 199 matching rows.

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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.