Zephrex-D

Manufacturer: Westport Pharmaceuticals | Elge Inc.
Effective date: 2013-05-15
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 22:36:10

Label at a glance#

ProductZephrex-D

Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE

Label structure8 sections

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each pill)

Pseudoephedrine HCl 30 mg

OTC - PURPOSE SECTION

Purpose

Nasal Decongestant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a

Poison Control Center right away. (1-800-222-1222)

INDICATIONS & USAGE SECTION

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

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 • high blood pressure • thyroid disease • diabetes

• trouble urinating due to an enlarged prostate gland

When using this product do not exceed recommended dose

Stop and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions: remove pill from sealed, plastic packaging before ingesting

swallow whole – do not crush, chew or dissolve

adults and children 12 years and over • take 2 pills every 4 to 6 hours

• do not take more than 8 pills in 24 hours

children ages 6 to under 12 years • take 1 pill every 4 to 6 hours

• do not take more than 4 pills in 24 hours

children ages under 6 years do not use this product in children

under 6 years of age

INACTIVE INGREDIENT SECTION

Inactive Ingredients croscarmellose sodium, guar gum, hydroxypropyl cellulose, lecithin,

microcrystalline cellulose, polyethylene glycol, polysorbate 80, vegetable oil, xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	8
1359003	Zephrex-D 30 MG Oral Tablet	PSN	8
1359003	pseudoephedrine hydrochloride 30 MG Oral Tablet [Zephrex-D]	SBD	8
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	8
1359003	Zephrex-D 30 MG Oral Tablet	SY	8

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53240-151-01	2019-11-27	C162847	48780-1	9855d018-eb82-cd31-e053-dbdaa90ab51a	d327b4ea-a232-4102-bd74-141196f687e0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53240-151-01	Zephrex-D	24 in 1 PACKAGE	TABLET	24		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53240-151	ZEPHREX-D (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WESTPORT PHARMACEUTICALS]	8	Legacy NDC, 1 package rows	20130717_d327b4ea-a232-4102-bd74-141196f687e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53240-151-01	EA - Each	53240-151	af2af9c0-4e73-4606-bab1-c1e777404117	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	8
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	8
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	8
HYDROGENATED PALM KERNEL OIL	INACTIVE INGREDIENT	FM8D1RE2VP	8
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	8
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	8
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	8
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	8

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Zephrex-D
Pseudoephedrine Hydrochloride
PSEUDOEPHEDRINE
CROSCARMELLOSE SODIUM
GUAR GUM
HYDROXYPROPYL CELLULOSE
LECITHIN, SOYBEAN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYSORBATE 80
HYDROGENATED PALM KERNEL OIL
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53240-151	53240-151-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
GUAR GUM	E89I1637KE	IACT
HYDROXYPROPYL CELLULOSE	RFW2ET671P	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
HYDROGENATED PALM KERNEL OIL	FM8D1RE2VP	IACT
XANTHAN GUM	TTV12P4NEE	IACT

Source Document#

Source XML

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 4 · 234 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, ORALLY DISINTEGRATING / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, DELAYED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, EXTENDED RELEASE / ORAL		864 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / OPHTHALMIC		26 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, CHEWABLE / ORAL		10 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	POWDER, FOR SUSPENSION / ORAL	11.25 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	FILM, EXTENDED RELEASE / TRANSDERMAL	19 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SPRAY, METERED / NASAL		96 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	187.6 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	LOTION / TOPICAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	INSERT / VAGINAL		3 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, COATED / ORAL	0.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / OPHTHALMIC		8 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	CAPSULE, EXTENDED RELEASE / ORAL		51 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	SOLUTION / TOPICAL		200 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, LIQUID FILLED / ORAL		24 mg	Exact identifier — unii candidate 78 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
af2ec66e-18ce-47da-a66f-887ceff6356e			d327b4ea-a232-4102-bd74-141196f687e0	2013-05-15	Warnings	Exact identifier spl id: af2ec66e-18ce-47da-a66f-887ceff6356e spl set id: d327b4ea-a232-4102-bd74-141196f687e0

Reported adverse events (FAERS/openFDA)#

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