FDA.reportPublic FDA data

Giltuss Sinus and Chest Congestion - Gil Pharmaceutical Corp

Manufacturer
Gil Pharmaceutical Corp
Effective date
2026-07-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-07-28 05:10:16

Label at a glance#

ProductGiltuss Sinus and Chest Congestion
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

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 Ingredient (in each tablet)

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

Nasal Decongestant

INDICATIONS & USAGE SECTION

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
  • clears stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • more than the recommended dosage
  • this product 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.In case of 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

Other information

  • store at room temperature, USP
  • do not use if blister seal is broken

INACTIVE INGREDIENT SECTION

Inactive ingredientsCroscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

OTC - QUESTIONS SECTION

Questions? Call 787-848-9114

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

GILTUSS®

SINUS & CHEST CONGESTION

20 TABLETS

NON-DROWSY. DYE FREE. PRESERVATIVE .SODIUM FREE

RELIEVES

  • STUFFY NOSE
  • NASAL CONGESTION
  • SINUS PRESSURE
  • CHEST CONGESTION
  • LOOSENS PHLEGM AND MUCUS

58552-332 Sinus Chest Congestion 11-2-201858552-332 Sinus Chest Congestion 11-2-2018

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-332-20EA - Each58552-332dde47d9b-7a85-421a-a50a-700684e4057a12019-04-11

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-33258552-332-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-10-09full-release2026-06-01 01:38:35
72025-03-10full-release2026-06-01 00:57:05

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
Giltuss Sinus and Chest CongestionGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2f2-df65-e053-2a91aa0a42fb2026-07-23WarningsExact identifier
ndc (package): 58552-332-20
ndc (product): 58552-332
ndc11 (package): 58552033220
spl id: 5746ab21-fd63-7ac4-e063-6394a90aa199
spl set id: 8591003c-c2f2-df65-e053-2a91aa0a42fb

Reported adverse events (FAERS/openFDA)#

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