Label at a glance#

ProductSudoGest

Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 30 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 2 for 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
trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and older	take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 years	take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 years	do not use this product in children under 6 years of age

Other information

SPL UNCLASSIFIED SECTION

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, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: SudoGest

GENERIC: Pseudoephedrine HCl

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0121-0

COLOR: red

SHAPE: ROUND

SCORE: No score

SIZE: 7 mm

IMPRINT: 44;112

PACKAGING: 30 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 1

INACTIVE INGREDIENT(S):

ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSCARMELLOSE SODIUM
TRIACETIN
FD&C RED NO. 40
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
SILICON DIOXIDE

Remedy_Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5053-24	EA - Each	0904-5053	5f294304-939e-4c0b-af84-6c0bb2f9bb11	1	2012-07-24
0904-5053-59	EA - Each	0904-5053	e6ec7cb2-becd-49b9-bed7-a75f6e1d8887	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

SudoGest
Pseudoephedrine HCl
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C RED NO. 40
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70518-0121	70518-0121-0
0904-5053

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
98f0bb19-0056-7f52-e053-2995a90a1528			edbab9d5-f715-4fe3-adfc-38d7d8d1cea6	2019-12-05	Warnings	Exact identifier spl set id: edbab9d5-f715-4fe3-adfc-38d7d8d1cea6

Reported adverse events (FAERS/openFDA)#

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