Phenagil CH

Manufacturer
Gil Pharmaceutical Corp | Contract Pharmacal Corp.
Effective date
2020-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:58:58

Label at a glance#

ProductPhenagil CH
Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

Uses Temporarily relieves runny nose and alleviates sneezing, itchy, watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.

Dosage and administration

Adults and Children 12 years of age and over: take 1 tablet every 6 hours. Do not exceed 4 tablets in 24 hours Children 6 to under 12 years of age: take 1/2 tablet every 6 hours as needed. Do not exceed 2 tablets in 24 hours Children under 6 years of age: Consult a physician.

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
Chlophedianol HCl 24 mg

OTC - PURPOSE SECTION

Purposes

Antihistamine
Nasal Decongestant
Cough Suppressant

Uses

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves runny nose and alleviates sneezing, itchy, watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.

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

• persistent or chronic cough such as occurs with smoking, asthma

• chronic bronchitis, or emphysema

• excessive phlegm (mucus)

Ask a doctor or pharmacist before 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

• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache

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 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 of age and over: take 1 tablet every 6 hours. Do not exceed 4 tablets in 24 hours
Children 6 to under 12 years of age:

take 1/2 tablet every 6 hours as needed.

Do not exceed 2 tablets in 24 hours

Children under 6 years of age: Consult a physician.

Other information

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.

OTC - QUESTIONS SECTION

Questions? Call 787-848-9114


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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58552-323-01

PHENAGIL® CH

ANTIHISTAMINE, NASAL DECONGESTANT AND ANTITUSSIVE
SUGAR FREE AND DYE FREE
Each tablet contains:
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCI 10 mg
Chlophedianol HCl 24 mg

100 Tablets

MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00716

Gil labelGil label

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-323PHENAGIL CH (PHENYLEPRINE HCL, CHLORPHENIRAMINE MALEATE AND CHLOPHEDIANOL HCL) TABLET [GIL PHARMACEUTICAL CORP]2Legacy NDC20201231_69f86794-cb83-8f21-e053-2a91aa0af778.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-323-01EA - Each58552-3235d546879-cb36-47c7-9077-8550cdba223212018-04-19

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
58552-32358552-323-02, 58552-323-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
387d0546-3092-ffc5-e063-6294a90ad11a69f86794-cb83-8f21-e053-2a91aa0af7782025-06-26WarningsExact identifier
spl set id: 69f86794-cb83-8f21-e053-2a91aa0af778

Reported adverse events (FAERS/openFDA)#

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