FDA.reportPublic FDA data

Gilphex

Manufacturer
Gil Pharmaceutical Corp. | Syntho Pharmaceuticals, Inc.
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:38:44

Label at a glance#

ProductGilphex
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

Do not exceed recommended doses in a  24 hour period Adults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours. Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours. Children under 6 years of age: ask a doctor.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients(in each tablet)

Guaifenesin 390 mg
Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not usethis product more than the recommended dosage, or 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease.
  • excessive phlegm (mucus).
  •  high blood pressure.
  • diabetes.
  • thyroid disease.
  • difficulty in urination due to enlargement of the 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, persistent headache, or excessive phlegm (mucus).
  • cough and congestion do not improve within 7 days or tend to recur.

These could be signs of  a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding,ask a health professional before use. Keep out of the reach of children.In case or accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended doses in a  24 hour period

  • Adults and Children 12 years and over:1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours.
  • Children 6 to 12 years:1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours.
  • Children under 6 years of age: ask a doctor.

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature, USP.
  •  do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide, Stearic Acid.

Questions? Call 787-848-9114

OTC - QUESTIONS SECTION

Manufactured for:

GIL PHARMACEUTICAL CORP.

Ponce, Puerto Rico 00716

Revised Label: 03/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gilphex ®Total Release - NDC-58552-336-01 - 100's Bottle Label

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2603663guaiFENesin 390 MG / phenylephrine HCl 10 MG Oral TabletPSN5
2603663guaifenesin 390 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD5

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-336-01Gilphex100 in 1 BOTTLETABLET1005
58552-336-02Gilphex2 in 1 BLISTER PACKTABLET25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-336-01EA - Each58552-3368ae47051-d076-4783-a98d-35f5b573910e12022-12-07

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-33658552-336-01, 58552-336-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-10-24full-release2026-06-01 00:30:04

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
GilphexGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp.e7c8fb97-02cf-4df6-b477-9ff69d6b675d2025-10-09WarningsExact identifier
ndc (package): 58552-336-02
ndc (package): 58552-336-01
ndc (product): 58552-336
ndc11 (package): 58552033601
ndc11 (package): 58552033602
spl id: 40b9f8d7-5f71-656f-e063-6294a90a3b8b
spl set id: e7c8fb97-02cf-4df6-b477-9ff69d6b675d

Reported adverse events (FAERS/openFDA)#

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