Rugby Nasal Decongestant

Manufacturer
Dispensing Solutions, Inc.
Effective date
2011-10-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:43

Label at a glance#

ProductRugby Nasal Decongestant Nasal Decongestant
Active ingredientPseudoephedrine Hydrochloride
Label structure11 sections

Indications and uses

temporarily relieves nasal congestion due to common cold hay fever upper respiratory allergies

Dosage and administration

take every 4-6 hours do not take more than 4 doses in 24 hours use only with enclosed dose cup. Do not use with any other device. adults & children 12 years and over 2 TSP children 6 to under 12 years 1 TSP children under 6 years do not use

Storage and handling

store at room temperature 15°-30°C (59°-86°F) protect from light

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each teaspoonful [TSP])

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 30 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to

  • common cold
  • hay fever
  • upper respiratory allergies

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • 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

  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or occur with fever

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4-6 hours
  • do not take more than 4 doses in 24 hours
  • use only with enclosed dose cup. Do not use with any other device.
adults & children 12 years and over2 TSP
children 6 to under 12 years1 TSP
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial raspberry flavor, citric acid, FD&C red #40, glycerin, methylparaben, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

Mfd. for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68258-8000-04NDC 68258-8000-04

NDC 68258-8000-04

NASAL DECONGESTANT
LIQUID

Pseudoephedrine HCl 30 mg

TEMPORARILY RELIEVES NASAL CONGESTION DUE TO COLDS AND ALLERGIES WITHOUT DROWSINESS

•SATISFACTION GUARANTEED•

4 fl oz
(118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049163pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN1
1049163pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD1
1049163pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-8000-42019-11-13C16284748780-197449f38-d202-f6ea-e053-dbdaa90aa703Rugby ® NASAL DECONGESTANT LIQUID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-8000-4Rugby Nasal DecongestantNasal Decongestant118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-8000RUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20111007_8cce0ece-0589-4894-8fd7-bba40eedaa52.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1850-85ML - Milliliter0536-1850233e0ba0-7061-44a9-abf5-c56adbecab3d12012-07-24
0536-1850-97ML - Milliliter0536-1850ad2ff551-290e-4f1f-849b-57e8962cf53412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8N1
PseudoephedrineACTIVE MOIETY7CUC9DDI9F1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOA1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
RaspberryINACTIVE INGREDIENT4N14V5R27W1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
SorbitolINACTIVE INGREDIENT506T60A25R1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68258-800068258-8000-4
0536-1850

Ingredients#

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

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

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 7 · 383 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Red no. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Red no. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii candidate
28 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C Red no. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, COATED / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRACARDIAC1.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
FD&C Red no. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7c6d5ac1-5bee-4c72-8240-10a7f25682608cce0ece-0589-4894-8fd7-bba40eedaa522011-10-06WarningsExact identifier
spl id: 7c6d5ac1-5bee-4c72-8240-10a7f2568260
spl set id: 8cce0ece-0589-4894-8fd7-bba40eedaa52

Reported adverse events (FAERS/openFDA)#

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