SudoGest

Manufacturer: A-S Medication Solutions
Effective date: 2021-04-14
Label type: HUMAN OTC DRUG LABEL
Version: 17
Source: full-release
Hydrated at: 2026-05-31 23:39:40

Label at a glance#

ProductSudoGest

Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE

Label structure10 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 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F) use by expiration date on package

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 60 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

diabetes
heart disease
high blood pressure
thyroid disease
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 pregrant 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 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0155

NDC: 50090-0155-1 30 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-3 12 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-4 20 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-5 15 TABLET, FILM COATED in a BOTTLE

Pseudoephedrine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049167	pseudoephedrine HCl 60 MG Oral Tablet	PSN	17
1049169	SudoGest 60 MG Oral Tablet	PSN	17
1049169	pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]	SBD	17
1049167	pseudoephedrine hydrochloride 60 MG Oral Tablet	SCD	17
1049169	Sudogest 60 MG Oral Tablet	SY	17

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0155-0	2023-01-30	C162847	48780-1	f386c649-c6b6-0266-e053-dadaa90a7c1a	SudoGest Nasal Decongestant
50090-0155-1	2023-01-30	C162847	48780-1	f386c649-c6b6-0266-e053-dadaa90a7c1a	SudoGest Nasal Decongestant
50090-0155-3	2023-01-30	C162847	48780-1	f386c649-c6b6-0266-e053-dadaa90a7c1a	SudoGest Nasal Decongestant
50090-0155-4	2023-01-30	C162847	48780-1	f386c649-c6b6-0266-e053-dadaa90a7c1a	SudoGest Nasal Decongestant
50090-0155-5	2023-01-30	C162847	48780-1	f386c649-c6b6-0266-e053-dadaa90a7c1a	SudoGest Nasal Decongestant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0155-0	SudoGest	24 in 1 BOTTLE	TABLET, FILM COATED	24	17
50090-0155-1	SudoGest	30 in 1 BOTTLE	TABLET, FILM COATED	30	17
50090-0155-3	SudoGest	12 in 1 BOTTLE	TABLET, FILM COATED	12	17
50090-0155-4	SudoGest	20 in 1 BOTTLE	TABLET, FILM COATED	20	17
50090-0155-5	SudoGest	15 in 1 BOTTLE	TABLET, FILM COATED	15	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0155	SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	17	Legacy NDC, 5 package rows	20210415_065ad37b-5200-4b45-a626-4b29452b4ec7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0155-1	EA - Each	50090-0155	de3e4ae3-fb9b-44ed-a7d1-4f3bfd513a3f	1	2018-08-13
50090-0155-3	EA - Each	50090-0155	3fa82e27-e412-4187-82c2-4697cd4c2be5	1	2018-08-13
50090-0155-4	EA - Each	50090-0155	0d6cc164-c872-4976-bc13-d78fad9b3cad	1	2018-08-13
50090-0155-5	EA - Each	50090-0155	21a1955c-e6e6-441e-bb3f-6e30e413941a	1	2018-08-13
0904-5125-46	EA - Each	0904-5125	3623143d-f36f-4353-b277-45df02278004	1	2012-07-24
0904-5125-59	EA - Each	0904-5125	3d202d8d-4e7e-45a3-ae64-7fa3baa531f1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

SudoGest
Pseudoephedrine Hydrochloride
PSEUDOEPHEDRINE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-0155	50090-0155-1, 50090-0155-3, 50090-0155-4, 50090-0155-5, 50090-0155-0
0904-5125

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT

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 · 205 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates

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
9d203c5a-1336-4a71-b937-48c1a8ba7fe4			065ad37b-5200-4b45-a626-4b29452b4ec7	2021-04-14	Warnings	Exact identifier spl id: 9d203c5a-1336-4a71-b937-48c1a8ba7fe4 spl set id: 065ad37b-5200-4b45-a626-4b29452b4ec7

Reported adverse events (FAERS/openFDA)#

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