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
Nasal Decongestant PE
- Manufacturer
- FRED'S, INC. | LNK International, Inc.
- Effective date
- 2018-12-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:42:37
Label at a glance#
ProductNasal Decongestant PE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure8 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 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
Contacts and useful links#
Websitewww.fredsinc.com
www.fredsinc.com
www.fredsinc.comLabel 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 dose.
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 (1-800-222-1222) 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 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Principal display panel
fred's®
Maximum Strength
Nasal Decongestant PE
Phenylephrine HCl 10 mg | Nasal Decongestant
Non-Drowsy
Sinus Pressure
Congestion
18 Tablets
fred's
LAB TESTED®
Lab Tested for Quality,
Fred Tested for Satisfaction
Compare to the
active ingredient in:
Sudafed PE®
Congestion*
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
fred's Promise
Not Happy With This Product?
Just Bring it Back for a Refund!
*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Sudafed PE® Congestion.
50844 REV0715F45344
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 3 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | 3 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| DEXTROSE MONOHYDRATE | INACTIVE INGREDIENT | LX22YL083G | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 3 |
Products#
Every source-derived product name is available through these pages.
- Nasal Decongestant PE
- Phenylephrine HCl
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CROSCARMELLOSE SODIUM
- DEXTROSE MONOHYDRATE
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- MALTODEXTRIN
- MICROCRYSTALLINE CELLULOSE
- SILICON DIOXIDE
- TRISODIUM CITRATE DIHYDRATE
- TITANIUM DIOXIDE
- CARBOXYMETHYLCELLULOSE SODIUM
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- LECITHIN, SOYBEAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-453 | 55315-453-44 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYRUP / ORAL | 26.5 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 100 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRALESIONAL | 15 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / TOPICAL | 186 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | LOTION / TOPICAL | 328 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, EXTENDED RELEASE / ORAL | 1036 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION, SOLUTION / INTRAVENOUS | 1188 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET / BUCCAL | 4 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | CAPSULE, DELAYED RELEASE / ORAL | 4.2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | GRANULE, FOR SUSPENSION / ORAL | 952 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION / INTRAVENOUS | 3480 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SYRUP / ORAL | 705 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | ELIXIR / ORAL | 120 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, DELAYED RELEASE / ORAL | 2834 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg |
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 |
|---|---|---|---|---|---|---|
| 3bbabdd0-6783-4490-b74b-58ad451cf750 | 490f7710-49c8-4bf5-a498-de058f026bb9 | 2018-12-12 | Warnings | 3bbabdd0-6783-4490-b74b-58ad451cf750 490f7710-49c8-4bf5-a498-de058f026bb9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.