FDA.reportPublic FDA data

Gilphex

Manufacturer
Syntho Pharmaceuticals, Inc.
Effective date
2022-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:49

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 use this 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

Manufactured by :

Syntho Pharmaceuticals, Inc.
Farmingdale, New York (NY) 11735
Revised Label: 03-22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gilphex ® Total Release - NDC-66576-336-01 - 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 TabletPSN1
2603663guaifenesin 390 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
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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66576-336-012024-01-30C16284748780-11030e365-2936-111a-e063-dadaa90a10e2GILPHEX ® TOTAL RELEASE EXPECTORANT AND NASAL DECONGESTANT YEAST FREE SODIUM FREE GLUTEN FREE PRESERVATIVE FREE SUGAR FREE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66576-336-01Gilphex100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66576-336GILPHEX (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SYNTHO PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20220614_87d867fd-e78d-4fbd-a5e4-5fcbb70559a3.zip

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
66576-33666576-336-01

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

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
e1501276-6d45-6ae8-e053-2a95a90abfa787d867fd-e78d-4fbd-a5e4-5fcbb70559a32022-06-13WarningsExact identifier
spl id: e1501276-6d45-6ae8-e053-2a95a90abfa7
spl set id: 87d867fd-e78d-4fbd-a5e4-5fcbb70559a3

Reported adverse events (FAERS/openFDA)#

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