FDA.reportPublic FDA data

Zephrex D

Manufacturer
L. Perrigo Company
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:36:41

Label at a glance#

ProductZephrex D
Active ingredientPSEUDOEPHEDRINE 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 2 softgels every 4 to 6 hours • do not take more than 8 softgels in 24 hours children ages 6 to under 12 years • take 1 softgel every 4 to 6 hours • do not take more than 4 softgels in 24 hours children under 6 years do not use this product in children under 6 years of age

Storage and handling

• store at 20-25 ° C (68-77 ° F) • do not use if blister unit is broken or torn

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 30 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged 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 occurs
  • symptoms do not improve within 7 days or occur with a 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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over

  • take 2 softgels every 4 to 6 hours
  • do not take more than 8 softgels in 24 hours

children ages 6 to under 12 years

  • take 1 softgel every 4 to 6 hours
  • do not take more than 4 softgels in 24 hours

children under 6 years

do not use this product in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • do not use if blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C red no. 40, gelatin, guar gum, hydroxypropylcellulose, lecithin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, sorbitan, sorbitol, titanium dioxide, vegetable oil, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW DOSAGE FORM

MAXIMUM STRENGTH

ZEPHREX-D ®

CONGESTION

Pseudoephedrine HCl 30 mg

Nasal Decongestant

METH BLOCKING TAREX® TECHNOLOGY ™

Non-Drowsy

Relieves

Nasal & Sinus Congestion

Sinus Pressure

Easy-to-take softgels.

Individually sealed.

Actual Size

Fast-acting nasal decongestant goes to work in as little as 30 minutes. With advanced meth-blocking technology for safer communities.

24 softgels

Zephrex-D image
Zephrex-D image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1430169pseudoephedrine HCl 30 MG Oral CapsulePSN5
1918218Zephrex-D 30 MG Oral CapsulePSN5
1918218pseudoephedrine hydrochloride 30 MG Oral Capsule [Zephrex-D]SBD5
1430169pseudoephedrine hydrochloride 30 MG Oral CapsuleSCD5
1918218Zephrex-D 30 MG Oral CapsuleSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0401-62Zephrex D1 in 1 BLISTER PACKCAPSULE, GELATIN COATED15
0113-0401-62Zephrex D24 in 1 CARTONCAPSULE, GELATIN COATED245
0113-0401-67Zephrex D1 in 1 BLISTER PACKCAPSULE, GELATIN COATED15
0113-0401-67Zephrex D48 in 1 CARTONCAPSULE, GELATIN COATED485

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0401ZEPHREX D (PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 4 package rows20241113_5468a7e2-361b-494f-9ca3-1b62f3819f65.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0401-62EA - Each0113-040144f4e884-befd-4206-862f-cf9d09dc39a312021-04-08

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
0113-04010113-0401-62, 0113-0401-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GUAR GUME89I1637KEIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT

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
Zephrex DPSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company5468a7e2-361b-494f-9ca3-1b62f3819f652024-11-11WarningsExact identifier
ndc (package): 0113-0401-67
ndc (package): 0113-0401-62
ndc (product): 0113-0401
ndc11 (package): 00113040162
ndc11 (package): 00113040167
spl id: 28086f51-f7d5-4c69-ad06-49aa164db301
spl set id: 5468a7e2-361b-494f-9ca3-1b62f3819f65

Reported adverse events (FAERS/openFDA)#

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