SU PHEDRINE PE

Manufacturer: Salado Sales, Inc. | LNK International, Inc.
Effective date: 2025-08-22
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 01:11:32

Label at a glance#

ProductSU PHEDRINE PE Non-Drowsy, Maximum Strength

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-426-9391

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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

CVP_®
HEALTH

COMPARE TO
SUDAFED PE^® CONGESTION
ACTIVE INGREDIENT*

NON-DROWSY
SU•PHEDRINE PE
PHENYLEPHRINE HYDROCHLORIDE
NASAL DECONGESTANT
MAXIMUM STRENGTH

18 TABLETS
10 mg EACH
1 PILL PER DOSE

RELIEVES NASAL &
SINUS CONGESTION
CONTAINS NO PSEUDOEPHEDRINE

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^® Congestion. 50844 REV0118M45344

Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049182	phenylephrine HCl 10 MG Oral Tablet	PSN	15
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	15

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57243-453-44	SU PHEDRINE PENon-Drowsy, Maximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1		15
57243-453-44	SU PHEDRINE PENon-Drowsy, Maximum Strength	18 in 1 BLISTER PACK	TABLET, FILM COATED	18		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

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

SU PHEDRINE PE Non-Drowsy, Maximum Strength
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 table
Product NDC	Package NDC
57243-453	57243-453-44

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
Name	UNII	Kind
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
DEXTROSE MONOHYDRATE	LX22YL083G	IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

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.

Inactive ingredient links page 1 of 1 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 30 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET, FILM COATED / ORAL		953 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	TROCHE / ORAL		4440 mg	Exact identifier — unii+route 10 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET / ORAL		320 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	FILM, SOLUBLE / ORAL		19 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EXTENDED RELEASE / ORAL		3239 mg	Exact identifier — unii+route 30 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii+route 30 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET / ORAL		11 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii+route 30 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 30 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	CAPSULE / ORAL		345 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	FILM, SOLUBLE / ORAL		19 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	LOZENGE / ORAL		175 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	GRANULE, FOR SUSPENSION / ORAL		952 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EXTENDED RELEASE / ORAL		3239 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii+route 30 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET, EXTENDED RELEASE / ORAL		92 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET / ORAL		320 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii+route 30 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	GRANULE, FOR SUSPENSION / ORAL		15009 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii+route 30 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	CAPSULE / ORAL		345 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	LOZENGE / ORAL		175 mg	Exact identifier — unii+route 30 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	TROCHE / ORAL		4440 mg	Exact identifier — unii+route 10 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET, EXTENDED RELEASE / ORAL		92 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii+route 30 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET, FILM COATED / ORAL		953 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	GRANULE, FOR SUSPENSION / ORAL		952 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii+route 30 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	GRANULE, FOR SUSPENSION / ORAL		15009 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii+route 30 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET / ORAL		11 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SUSPENSION / ORAL		6040 mg	Exact identifier — unii+route 30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii+route 30 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SUSPENSION / ORAL		6040 mg	Exact identifier — unii+route 30 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SU PHEDRINE PE Non-Drowsy, Maximum Strength	PHENYLEPHRINE HCL	Salado Sales, Inc.	9056fa58-d6aa-4df5-97e0-9be3f2332f86	2025-08-22	Warnings	Exact identifier ndc (package): 57243-453-44 ndc (product): 57243-453 ndc11 (package): 57243045344 spl id: 5ae58203-4d1e-42ed-bbbe-e27aca71dc91 spl set id: 9056fa58-d6aa-4df5-97e0-9be3f2332f86

Reported adverse events (FAERS/openFDA)#

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