Phenagil Tablet
FDA Label NDC 58552-351

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 58552-351). 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, otc - purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before you 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

→ Otc - Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before You Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdosage

→ Directions

→ Other Informaton

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg

Otc - Purpose

Purposes
Antihistamine
Nasal Decongestant

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

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 You 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children 12 years and over:	take one tablet every 4 hours. Do not take more than 6 tablets in a 24 hour period.
Children 6 to 12 years of age:	Take 1/2 tablet every 4 hours. Do not take more than 3 tablets in a 24 hour period.
Children under 6 years of age:	Do not use this product.