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
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure
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
store at controlled room temperature 15˚-30˚C (59˚-86˚F) see end flap for expiration date and lot number
Pseudoephedrine HCl 60 mg
Nasal decongestant
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available
MAJOR®
FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
NDC 0904-5125-59
SudoGest™
NASAL DECONGESTANT 60 mg
Pseudoephedrine Hydrochloride 60 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever
Without Drowsiness
100 TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 Rev. 0807L11302
Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
Repacked by H.J. Harkins Company, Inc.
Nipomo, CA 93444
Rev. 10/11 Re-order No. 700324

Product Packaging
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1049167 | pseudoephedrine HCl 60 MG Oral Tablet | PSN | 2 |
| 1049169 | SudoGest 60 MG Oral Tablet | PSN | 2 |
| 1049169 | pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest] | SBD | 2 |
| 1049167 | pseudoephedrine hydrochloride 60 MG Oral Tablet | SCD | 2 |
| 1049169 | Sudogest 60 MG Oral Tablet | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52959-260-00 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d544-f6ea-e053-dbdaa90aa703 | SudoGest Nasal Decongestant |
| 52959-260-20 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d544-f6ea-e053-dbdaa90aa703 | SudoGest Nasal Decongestant |
| 52959-260-24 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d544-f6ea-e053-dbdaa90aa703 | SudoGest Nasal Decongestant |
| 52959-260-25 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d544-f6ea-e053-dbdaa90aa703 | SudoGest Nasal Decongestant |
| 52959-260-30 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d544-f6ea-e053-dbdaa90aa703 | SudoGest Nasal Decongestant |
| 52959-260-40 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d544-f6ea-e053-dbdaa90aa703 | SudoGest Nasal Decongestant |
| 52959-260-60 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d544-f6ea-e053-dbdaa90aa703 | SudoGest Nasal Decongestant |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-260-00 | SudoGest | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 2 | |
| 52959-260-20 | SudoGest | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | 2 | |
| 52959-260-24 | SudoGest | 24 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 24 | 2 | |
| 52959-260-25 | SudoGest | 25 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 25 | 2 | |
| 52959-260-30 | SudoGest | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 2 | |
| 52959-260-40 | SudoGest | 40 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 40 | 2 | |
| 52959-260-60 | SudoGest | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-260-00 | EA - Each | 52959-260 | dbc74f60-b33b-4ddd-ad2c-c0d44ff74c96 | 1 | 2012-07-24 |
| 52959-260-20 | EA - Each | 52959-260 | 01d4c7c9-7d60-4120-b00f-9ba3afb00190 | 1 | 2012-07-24 |
| 52959-260-24 | EA - Each | 52959-260 | afea45be-f83b-4179-bdef-8e24eea7bfd8 | 1 | 2012-07-24 |
| 52959-260-25 | EA - Each | 52959-260 | e3887d04-ae08-41c0-be12-2bb2beb33609 | 1 | 2012-07-24 |
| 52959-260-30 | EA - Each | 52959-260 | a2cfc6ff-fbf1-4f0b-ab60-d9c4824d0db1 | 1 | 2012-07-24 |
| 52959-260-40 | EA - Each | 52959-260 | 95e5bace-c2f5-4efc-9d1b-4b9e9ce8b040 | 1 | 2012-07-24 |
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | 2 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52959-260 | 52959-260-00, 52959-260-20, 52959-260-24, 52959-260-25, 52959-260-30, 52959-260-40, 52959-260-60 |
| 0904-5125 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SOLUTION / RECTAL | 8 %w/v | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, EXTENDED RELEASE / ORAL | 400 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER, FOR SOLUTION / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAVENOUS | 203.5 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, SUGAR COATED / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | OINTMENT / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 133 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 133 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CONCENTRATE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 68ccbad3-6dd8-41d3-8eb2-7babb7d1a44a | f2ef2293-8d05-44ee-987d-898a72eb5735 | 2012-01-19 | Warnings | 68ccbad3-6dd8-41d3-8eb2-7babb7d1a44a f2ef2293-8d05-44ee-987d-898a72eb5735 |
Adverse event summaries are temporarily unavailable. Other product information remains available.