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
SudoGest
- Manufacturer
- Major Pharmaceuticals | LNK International, Inc.
- Effective date
- 2026-09-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-09-24 01:01:06
Label at a glance#
Productpseudoephedrine HCl
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours. children under 12 years: do not use
Storage and handling
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN use by expiration date on package store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Pseudoephedrine HCl 60 mg
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Warnings
Do not use
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
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
When using this product
do not exceed recommended dosage.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with fever
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
- children under 12 years: do not use
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- use by expiration date on package
- store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
Inactive ingredients
colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid
Questions or comments?
1-800-426-9391
Principal display panel
MAJOR®
NDC 0904-7669-06
maximum strength
pseudoephedrine
HCl
pseudoephedrine HCl 60 mg
nasal decongestant
relieves:
• sinus pressure
• sinus congestion
dye free
non-drowsy
actual size
50 tablets
(5 x 10) unit dose
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0309047669066 | GTIN-13: 0309047669066 EAN-13: 0309047669066 GTIN-12: 309047669066 UPC-A: 309047669066 GTIN storage (14 digits): 00309047669066 | major-44-113-1.jpg |
Products#
Every source-derived product name is available through these pages.
- pseudoephedrine HCl
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- SILICON DIOXIDE
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
- ANHYDROUS LACTOSE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-7669 | 0904-7669-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.