FDA.reportPublic FDA data

YYBA (as PLD) - WELMATE - Nasal Decongestant PE Tablets, 10 MG (73581-204)

Manufacturer
YYBA CORP
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:06:29

Label at a glance#

ProductNASAL DECONGESTANT PE 10mg
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 older: take 1 tablet 4 hours. Do not take more than 6 tablets in 24 hours children under 12 years: ask a doctor

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 useif you are taking a prescription monoamine oxidase inhibitor (MA0l)(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0l drug. If you do not know if your prescription drug contains an MA0l, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

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

If pregnant or breast-feeding,as 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 [1-800-222-1222]

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older:

take 1 tablet 4 hours. Do not take more than 6 tablets in 24 hours

  • children under 12 years:ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40. lecithin, magnesium stearate, maltrodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-866-933-6337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Nasal Decongestant_10mg.jpg01b LBL_Nasal Decongestant_10mg.jpg

01b DF1_Nasal Decongestant_10mg.jpg01b DF1_Nasal Decongestant_10mg.jpg

01b DF2_Nasal Decongestant_10mg.jpg01b DF2_Nasal Decongestant_10mg.jpg

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73581-204-02NASAL DECONGESTANT PE10mg200 in 1 BOTTLETABLET2006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73581-204NASAL DECONGESTANT PE 10MG (PHENYLPHRINE HCL) TABLET [YYBA CORP]6Current NDC, Legacy NDC, 1 package rows20240104_05824fc4-ef3f-4ebb-b601-252f76ad60ef.zip

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
73581-20473581-204-02

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
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSE MONOHYDRATELX22YL083GIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85)2YGO1190APIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM

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
NASAL DECONGESTANT PE 10mgPHENYLPHRINE HCLYYBA CORP05824fc4-ef3f-4ebb-b601-252f76ad60ef2024-01-03WarningsExact identifier
ndc (package): 73581-204-02
ndc (product): 73581-204
ndc11 (package): 73581020402
spl id: 0e13a1f1-87bb-b26e-e063-6294a90a87f8
spl set id: 05824fc4-ef3f-4ebb-b601-252f76ad60ef

Reported adverse events (FAERS/openFDA)#

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