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
Sinus Congestion PE
- Manufacturer
- L.N.K. International, Inc. | LNK International, Inc.
- Effective date
- 2024-06-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:00:13
Label at a glance#
ProductSinus Congestion PE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor
Storage and handling
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Phenylephrine HCl 10 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 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: ask a doctor
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Questions or comments?
1-800-426-9391
Principal Display Panel
SOUNDBODY™
*Compare to the active ingredient
in SUDAFED PE® SINUS CONGESTION
NDC 50844-443-07
MAXIMUM STRENGTH
Sinus Congestion PE
Phenylephrine HCl 10 mg, Nasal Decongestant
Relieves Sinus Pressure and Congestion
Non Drowsy
Actual Size
36 TABLETS
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark SUDAFED PE®
SINUS CONGESTION. 50844 ORG082045307
Manufactured for Big Lots Stores, Inc.
by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
V#733000 ITEM#022745307BLBX
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sinus Congestion PE
- Phenylephrine HCl
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CROSCARMELLOSE SODIUM
- DEXTROSE MONOHYDRATE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- FD&C RED NO. 40
- LECITHIN, SOYBEAN
- MAGNESIUM STEARATE
- MALTODEXTRIN
- MICROCRYSTALLINE CELLULOSE
- SILICON DIOXIDE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- TRISODIUM CITRATE DIHYDRATE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50844-443 | 50844-443-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5e61ba36-66ee-42d9-b9d8-7749ec10fdbc | ac096e28-4c4d-40b2-b14b-0616cbacfea3 | 2024-06-24 | Warnings | 5e61ba36-66ee-42d9-b9d8-7749ec10fdbc ac096e28-4c4d-40b2-b14b-0616cbacfea3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.