Nasal Decongestant

Manufacturer: Proficient Rx LP
Effective date: 2024-10-01
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:29:06

Label at a glance#

ProductNasal Decongestant

Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE

Label structure9 sections

Dosage and administration

adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-645-2158

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 30 mg

Purpose

OTC - PURPOSE SECTION

Nasal Congestant

Use(s)

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily restores freer breathing through the nose

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 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

diabetes
high blood pressure
heart disease
thyroid disease
trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

do not use more than directed

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and older	take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 years	take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 years	do not use

Other information

SPL UNCLASSIFIED SECTION

store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

compare to Sudafed®

Decongestant active ingredient*

NDC 63187-344-24

Nasal Decongestant

pseudoephedrine HCl 30 mg

Temporarily relieves:

• nasal congestion due to cold & allergies withoout drowsiness

24 tablets, 30 mg each

TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

Rev 04/13

R-29

DISTRIBUTED BY:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
Error! Hyperlink reference not valid.

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	5
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	5

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-344-24	Nasal Decongestant	1 in 1 CARTON	TABLET	1		5
63187-344-24	Nasal Decongestant	24 in 1 BLISTER PACK	TABLET	24		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-344	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 2 package rows	20241025_4eab4344-d95e-4b19-a21e-9c8ad033863a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-3607-35	EA - Each	0536-3607	42467ecb-1fff-4285-879d-82d9e9b9aa0e	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
12-HYDROXYSTEARIC ACID	INACTIVE INGREDIENT	933ANU3H2S	1
ACER SACCHARUM POLLEN	INACTIVE INGREDIENT	V38QUQ7861	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Nasal Decongestant
Pseudoephedrine HCl
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
CALCIUM SULFATE, UNSPECIFIED FORM
CARNAUBA WAX
FD&C RED NO. 40
GELATIN, UNSPECIFIED
KAOLIN
ANHYDROUS LACTOSE
MAGNESIUM SILICATE
SHELLAC
SILICON DIOXIDE
12-HYDROXYSTEARIC ACID
ACER SACCHARUM POLLEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63187-344	63187-344-24
0536-3607

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CALCIUM SULFATE, UNSPECIFIED FORM	WAT0DDB505	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
KAOLIN	24H4NWX5CO	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
MAGNESIUM SILICATE	9B9691B2N9	IACT
SHELLAC	46N107B71O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
12-HYDROXYSTEARIC ACID	933ANU3H2S	IACT
ACER SACCHARUM POLLEN	V38QUQ7861	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 1 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET / ORAL	150 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET / ORAL	10 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET / ORAL	10 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET / ORAL	150 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	TABLET / ORAL		2734 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	TABLET / ORAL		2734 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	TABLET / ORAL		2734 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET / ORAL	10 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET / ORAL	150 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii+route+dosage form 3 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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Proficient Rx LP	4eab4344-d95e-4b19-a21e-9c8ad033863a	2024-10-01	Warnings	Exact identifier ndc (package): 63187-344-24 ndc (product): 63187-344 ndc11 (package): 63187034424 spl id: 076ef551-acae-42de-8948-3e6b0273ebc5 spl set id: 4eab4344-d95e-4b19-a21e-9c8ad033863a
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Rugby Laboratories	775f97c0-6f82-49a8-82ac-f1a73920c3ec	2024-01-11	Warnings	Exact identifier ndc (product): 0536-3607

Reported adverse events (FAERS/openFDA)#

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