PHENAGIL

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#

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.   • temporarily restores freer breathing ...

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.

  • temporarily 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

Hydroxypropyl Methylcellulose, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate and Polyethylene Glycol.

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

Manufactured by:
Syntho Pharmaceuticals, Inc.
Farmingdale, New York (NY) 11735
Label revised: 04/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHENAGIL ® CH - NDC 66576-337-01 - 100's Bottle Label.

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2603661chlorpheniramine maleate 3.5 MG / dextromethorphan HBr 29 MG / phenylephrine HCl 10 MG Oral TabletPSN1
2603661chlorpheniramine maleate 3.5 MG / dextromethorphan hydrobromide 29 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
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f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66576-337-01PHENAGIL100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66576-337PHENAGIL (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) TABLET [SYNTHO PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20220614_464bddda-ab2b-44c8-a4e1-4884585fc29c.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
66576-33766576-337-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
e1500f2d-b9a9-4ed5-e053-2a95a90a139d464bddda-ab2b-44c8-a4e1-4884585fc29c2022-06-13WarningsExact identifier
spl id: e1500f2d-b9a9-4ed5-e053-2a95a90a139d
spl set id: 464bddda-ab2b-44c8-a4e1-4884585fc29c

Reported adverse events (FAERS/openFDA)#

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