Drugplain

PHENAGIL 3.5 mg/1

Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL · TABLET · Gil Pharmaceutical Corp.

No Recall History
Plain English

PHENAGIL is a tablet containing chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl at 3.5 mg/1, taken oral. Manufactured by Gil Pharmaceutical Corp..

Key Facts

Brand Name
PHENAGIL
Generic Name
Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL
NDC Code (Product)
58552-337
Manufacturer
Gil Pharmaceutical Corp.
Strength
3.5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
05/26/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea2 reports
nausea2 reports
bone pain1 reports
herpes zoster1 reports
insomnia1 reports
rash1 reports
therapy cessation1 reports
vomiting1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses 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 & Administration

Directions Adults and Children12 years of age and over: take 1 tablet every 4-6 hours. Do not exceed 6 tablets in 24 hours Children 6 to under 12 years of age: 1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 our period Children under 6 years of age: Consult a physician.

Warnings

Do not use 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 • 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 use if you are taking sedatives or tranquilizers When using this product • 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 • nervousness, dizziness, or sleeplessness occurs • symptoms do not improve within 7 days or occur with a fever. If pregnant or breast-feeding , ask a health professional before use. Keep out of the reach of children. In case of overdose

Frequently Asked Questions

What is PHENAGIL used for?

PHENAGIL contains Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL. It is a tablet taken oral. Consult your doctor for specific uses.

Is PHENAGIL a controlled substance?

PHENAGIL is not classified as a controlled substance by the DEA.

What is the generic name for PHENAGIL?

The generic name for PHENAGIL is Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL. There are no other listed brand versions of Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL.

What is the NDC code for PHENAGIL 3.5 mg/1?

The NDC (National Drug Code) for PHENAGIL 3.5 mg/1 is 58552-337, listed by Gil Pharmaceutical Corp..

Product NDC

58552-337

Package NDC

58552-337-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)