FDA.reportPublic FDA data

Suphedrine PE Congestion

Manufacturer
FRED'S, INC. | LNK International, Inc.
Effective date
2020-06-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:26:31

Label at a glance#

ProductSuphedrine PE Congestion
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure9 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 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 10 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

  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

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 pregnant 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fred's
Pharmacy

NDC 55315-953-44

Compare to the active ingredient in:
Sudafed PE® Congestion*

SUPHEDRINE PE
CONGESTION
Phenylephrine HCl 10 mg - Nasal Decongestant

SINUS & NASAL                                        SINUS PRESSURE
CONGESTION                                           NON-DROWSY

MAXIMUM
STRENGTH

Actual Size

18 TABLETS

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Congestion.

50844     REV0118G45344

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction
          guaranteed
Questions or comments: 1-855-331-FRED (3733)

Freds 44-453
Freds 44-453

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-95355315-953-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
35fdd072-ef47-4be0-ae6f-fadf78c80fd88b473153-3e99-4afe-86ed-6f47e06b0f252020-06-11WarningsExact identifier
spl id: 35fdd072-ef47-4be0-ae6f-fadf78c80fd8
spl set id: 8b473153-3e99-4afe-86ed-6f47e06b0f25

Reported adverse events (FAERS/openFDA)#

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