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 - Major Pharmaceuticals
- Manufacturer
- Major Pharmaceuticals
- Effective date
- 2026-05-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-06-04 05:10:15
Label at a glance#
ProductSudoGest
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
take every 4-6 hours do not take more than 4 doses in 24 hours adults & children 12 years & over 2 tablets children 6 to under 12 years 1 tablets children under 6 years do not use
Contacts and useful links#
Websitewww.majorpharmaceuticals.com
www.majorpharmaceuticals.com
www.majorpharmaceuticals.comLabel contents#
Full prescribing information#
Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine HCl 30 mg
OTC - PURPOSE SECTION
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 SECTION
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4-6 hours
- do not take more than 4 doses in 24 hours
adults & children 12 years & over | 2 tablets |
children 6 to under 12 years | 1 tablets |
children under 6 years | do not use |
Other information
- Store between 15° - 30°C (59° - 86°F)
- use by expiration date on package
INACTIVE INGREDIENT SECTION
calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.
Questions or comments?
1-800-616-2471
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 www.majorpharmaceuticals.com
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed®.
Rev. 08/22 M-29 Re-order No. 700918 R51444
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MAJOR ®
NDC 0904-6727-60
Non Drowsy SudoGest TM
Nasal Decongestant
Pseudoephedrine Hydrochloride 30mg
FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever without drowsiness
Compare to the active ingredient in Sudafed® Sinus Congestion*
100 Tablets
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6727-60 | EA - Each | 0904-6727 | ccc5d814-e951-423c-a777-ed9bbc2e5247 | 1 | 2019-11-12 |
Products#
Every source-derived product name is available through these pages.
- SudoGest
- Pseudoephedrine Hydrochloride
- STARCH, CORN
- SILICON DIOXIDE
- LACTOSE MONOHYDRATE
- ANHYDROUS LACTOSE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- TITANIUM DIOXIDE
- KAOLIN
- CALCIUM SULFATE ANHYDROUS
- CALCIUM CATION
- CARNAUBA WAX
- CROSCARMELLOSE SODIUM
- CROSCARMELLOSE
- FD&C RED NO. 40
- SHELLAC
- STEARIC ACID
- SUCROSE
- PSEUDOEPHEDRINE
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- GELATIN
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-6727 | 0904-6727-60 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-08-13 | full-release | 2026-06-01 01:12:10 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SudoGest | PSEUDOEPHEDRINE HYDROCHLORIDE | Major Pharmaceuticals | 78faa497-6743-b85b-e053-2a91aa0ae822 | 2026-05-12 | Warnings | 0904-6727-60 0904-6727 00904672760 51a15b06-2e4f-7b5a-e063-6294a90aac61 78faa497-6743-b85b-e053-2a91aa0ae822 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.