PHENAGIL

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 01:01:17

Label at a glance#

ProductPHENAGIL
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

Temporarily relieves: cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. temorarily restores freer breathing through the nose.

Dosage and administration

Adults and Children 12 years and over. : Take one tablet every 6-8 hours. Do not take more than 4 tablets in a 24 hour period. Children 6 to 12 years of age : Take 1/2 tablet every 6-8 hours. Do not take more than 2 tablets in a 24 hour period. Children under 6 years : Consult a doctor.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each tablet)

Chlorpheniramine maleate 3.5 mg
Dextromethorphan HBr 29 mg
Phenylephrine HCI 10 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine
Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves:
  • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.
  • nasal congestion due to the common cold, hay fever or other upper respiratory allergies.
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose.
    • sneezing.
    • itchy, watery eyes.
    • itching of the nose or throat.
    • temorarily restores freer breathing through the nose.

Warnings

WARNINGS SECTION

Do not use

  • to sedate a child or to make a child sleepy.
  • 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.
  • glaucoma.
  • cough that occurs with too much phlegm (mucus).
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers.
  • taking any other oral nasal decongestant or stimulant.

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed.
  • may cause drowsiness.
  • avoid alcoholic beverages.
  • alcohol, sedatives, and tranquilizers may increase drowsiness.
  • be careful when driving a motor vehicle or operating machinery.
  • excitability may occur, especially in children.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy, or sleepless.
  • symptoms do not get better within 7 days or are accompanied by fever.
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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 reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and Children 12 years and over.: Take one tablet every 6-8 hours.
  • Do not take more than 4 tablets in a 24 hour period.
  • Children 6 to 12 years of age: Take 1/2 tablet every 6-8 hours.
  • Do not take more than 2 tablets in a 24 hour period.
  • Children under 6 years: Consult a doctor.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-787-848-9114,Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.

MANUFACTURED FOR:
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00716

Label revised: 08/2026

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHENAGIL ®CH - NDC 58552-352-01 - 100's Bottle Label

image descriptionimage description

PHENAGIL ®CH - NDC 58552-352-02 - Blister Label

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-35258552-352-01, 58552-352-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corpdfcf1231-8271-458d-b375-e328d6fd4e9b2026-09-02WarningsExact identifier
ndc (package): 58552-352-01
ndc (package): 58552-352-02
ndc (product): 58552-352
ndc11 (package): 58552035202
ndc11 (package): 58552035201
spl id: 5a7f6292-1779-5162-e063-6294a90a27e4
spl set id: dfcf1231-8271-458d-b375-e328d6fd4e9b

Reported adverse events (FAERS/openFDA)#

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