Phenagil Tablet
FDA Label NDC 58552-352

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp for the product Phenagil (NDC 58552-352). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purposes, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Purposes

→ Uses

→ Warnings

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package Label.principal Display Panel

Drug Facts

Active ingredients
(in each tablet)

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

Purposes

Antihistamine
Cough suppressant
Nasal decongestant

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.

Warnings

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

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

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

When Using This Product

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

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.