FDA.reportPublic FDA data

Non-Drowsy Nasal Decongestant Phenylephrine Hydrochloride Tablets 10mg

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:32

Label at a glance#

ProductNon-Drowsy Nasal Decongestant PE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 10mg

INACTIVE INGREDIENT SECTION

microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10

DOSAGE & ADMINISTRATION SECTION

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

adults and children 12 years and over
  • 1 tablet every 4 hours
  • Do not take more than 6 tablets in 24 hours
children under 12 years

Ask a doctor

INDICATIONS & USAGE SECTION

* temporarily relieves sinus congestion and pressure

* temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

WARNINGS 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 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
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

*When using this product do not exceed recommended dose.

*Stop use 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.

*Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PURPOSE SECTION

Nasal Decongestant

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN3
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD3

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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70692-100-242022-01-28C16284748780-1d6a99b39-ca8c-a426-e053-dadaa90af4c2Non-Drowsy Nasal Decongestant Phenylephrine Hydrochloride Tablets 10mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-100-24Non-Drowsy Nasal Decongestant PE24 in 1 BLISTER PACKTABLET, FILM COATED243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-100NON-DROWSY NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [STRIVE PHARMACEUTICALS INC.]3Legacy NDC, 1 package rows20201014_64e2a606-3d47-f255-e053-2991aa0a519d.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
70692-10070692-100-24

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
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STEARIC ACID4ELV7Z65APIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL 1000000HZ58M6D839IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
b1935570-d420-ab2e-e053-2995a90ae8d864e2a606-3d47-f255-e053-2991aa0a519d2020-10-13WarningsExact identifier
spl id: b1935570-d420-ab2e-e053-2995a90ae8d8
spl set id: 64e2a606-3d47-f255-e053-2991aa0a519d

Reported adverse events (FAERS/openFDA)#

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