FDA.reportPublic FDA data

PHARBINEX-PE

Manufacturer
Pharbest Pharmaceuticals, Inc.
Effective date
2018-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:59

Label at a glance#

ProductPHARBINEX-PE
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves symptoms associated with cough, the common cold, hay fever or upper respiratory allergies helps loosen phlegm(mucus) thin bronchial secretions drain bronchial tubes make coughs more productive loosen nasal congestion clear stuffy nose clear nasal passageways shrinks swollen membranes

Storage and handling

store at room temperature (15°-30°C)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg

Phenylephrine HCl 10mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms associated with cough, the common cold, hay fever or upper respiratory allergies

  • helps loosen phlegm(mucus)
  • thin bronchial secretions
  • drain bronchial tubes
  • make coughs more productive
  • loosen nasal congestion
  • clear stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

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 MAOI drug. If you do not know whether your prescription drug contains an MAOI, ask your doctor or pharmacist before using this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm (mucus)
  • difficulty in urination due to enlargement of prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash or persistent headache
  • cough and congestion do not improve within 7 days or tend to recur

These could be signs of a serious illness.

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

  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • do not exceed 6 doses in 24 hours or as directed by doctor

adults and children 12 years of age and over

take 1 caplet every 4 hours as needed

children 6 to under 12 years of age

take ½ caplet every 4 hours as needed

children under 6 years of age

consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST 

NDC 16103-0389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg & Phenylephrine HCl 10mg

Expectorant & Nasal Decongestant

30 CAPLETS

Pharbinex PE Caplet Product Label ImagePharbinex PE Caplet Product Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1304111guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral TabletPSN1
1304111guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-389-042022-01-28C16284748780-1d6a99b39-500e-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-389-04PHARBINEX-PE30 in 1 BOTTLE, PLASTICTABLET, COATED301
16103-389-04PHARBINEX-PE1 in 1 CARTONTABLET, COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-389PHARBINEX-PE (GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG) TABLET, COATED [PHARBEST PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20190328_cad73d08-a439-446f-aaa9-d1fd18ec1e54.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16103-38916103-389-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

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
0615f444-f14a-426f-975a-822f67e0a79fcad73d08-a439-446f-aaa9-d1fd18ec1e542018-05-01WarningsExact identifier
spl id: 0615f444-f14a-426f-975a-822f67e0a79f
spl set id: cad73d08-a439-446f-aaa9-d1fd18ec1e54

Reported adverse events (FAERS/openFDA)#

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