FDA.reportPublic FDA data

ACTIFED

Manufacturer
Belmora LLC
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:23:04

Label at a glance#

ProductACTIFED
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporarily relieves • nasal congestion due to the common cold, hay fever or other upper respiratory allergies • sinus congestion and pressure

Dosage and administration

• do not use more than directed Adults & Children:  (12 years & older)  Take 2 tablets every 4-6 hours.  Do not take more than 12 tablets in 24 hours. Children under 12 years:  Ask a doctor

Storage and handling

• store at room temperature 59°-86° F (15°-30° C). • tamper evident sealed packets. • do not use any opened or torn packets

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 5mg

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 • sinus congestion and pressure

Warnings

WARNINGS SECTION

Do not use • If you are now taking a prescription monoamineoxidase 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.

When using this product do not exceed recommended dosage

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever
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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• do not use more than directed

Adults & Children:
 (12 years & older)		 Take 2 tablets every 4-6 hours.
 Do not take more than 12 tablets in 24 hours.
Children under 12 years: Ask a doctor

Other Information

STORAGE AND HANDLING SECTION

• store at room temperature 59°-86° F (15°-30° C).
• tamper evident sealed packets.
• do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-779-2877 M-F 9AM-5PM EST
Belmora LLC 3033 Wilson Blvd. Suite 700 Arlington, VA 22201

SPL UNCLASSIFIED SECTION

Quick Nasal Decongestant Relief!
Non-Drowsy/Sugar Free

KEEP THE BOX FOR COMPLETE PRODUCT INFORMATION

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTIFED-119ACTIFED-119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299145phenylephrine HCl 5 MG Oral TabletPSN2
1299145phenylephrine hydrochloride 5 MG Oral TabletSCD2
1299145phenylephrine HCl 5 MG Oral TabletSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27854-119-01ACTIFED1 in 1 POUCHTABLET12
27854-119-01ACTIFED50 in 1 BOXTABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-119ACTIFED (PHENYLEPHRINE HYDROCHLORIDE) TABLET [BELMORA LLC]22 package rows20241009_65c23d86-9634-4d9f-93cd-9efa866cd7f5.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27854-11927854-119-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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
ca9feedc-4fe2-4a7b-b8ea-de622b63e98b65c23d86-9634-4d9f-93cd-9efa866cd7f52024-10-04WarningsExact identifier
spl id: ca9feedc-4fe2-4a7b-b8ea-de622b63e98b
spl set id: 65c23d86-9634-4d9f-93cd-9efa866cd7f5

Reported adverse events (FAERS/openFDA)#

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