PHENAGIL - Gil Pharmaceutical Corp

Manufacturer
Gil Pharmaceutical Corp
Effective date
2026-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-04 01:01:24

Label at a glance#

ProductPHENAGIL
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper-respiratory allergies: • runny nose • sneezing • itchy, watery eyes • nasal congestion • itching of the nose or throat • sinus congestion and pressure

Dosage and administration

Adults and children 12 years and over: take one tablet every 4 hours. Do not take more than 6 tablets in a 24 hour period. Children 6 to 12 years of age: Take 1/2 tablet every 4 hours. Do not take more than 3 tablets in a 24 hour period. Children under 6 years of age: Do not use this product.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

Purposes
Antihistamine
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper-respiratory allergies:
• runny nose • sneezing • itchy, watery eyes • nasal congestion • itching of the nose or throat • sinus congestion and pressure

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before you use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever.

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.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:

take one tablet every 4 hours. Do not take more than 6 tablets in a 24 hour period.

Children 6 to 12 years of age:

Take 1/2 tablet every 4 hours. Do not take more than 3 tablets in a 24 hour period.

Children under 6 years of age:

Do not use this product.

Other Informaton

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Magnesium Stearate, Microcrystalline Cellulose and Lactose Monohydrate.

OTC - QUESTIONS SECTION

Questions? Call 787-848-9114

Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58552-351-01
PHENAGIL

ANTIHISTAMINE AND NASAL DECONGESTANT

SUGAR FREE AND DYE FREE

Each tablet contains:
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCI 10 mg

100 Tablets

MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

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Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-35158552-351-01, 58552-351-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corpfa8510d8-d50a-4743-ba87-a12e9ab431252026-09-02WarningsExact identifier
ndc (package): 58552-351-01
ndc (package): 58552-351-02
ndc (product): 58552-351
ndc11 (package): 58552035102
ndc11 (package): 58552035101
spl id: 5a7f5d31-ca01-4cf1-e063-6294a90a3e9d
spl set id: fa8510d8-d50a-4743-ba87-a12e9ab43125

Reported adverse events (FAERS/openFDA)#

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