Drug Facts
Active Ingredients (in each tablet)
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg
Phenagil Tablet
FDA Label NDC 58552-322
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 58552-322). 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 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
Otc - Purpose
Purposes
Antihistamine
Nasal Decongestant
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
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.
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 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. |
Other Informaton
• store at room temperature, USP
• do not use if imprinted safety seal under cap is broken or missing.
Inactive Ingredient
Magnesium Stearate, Microcrystalline Cellulose and Silica.
Otc - Questions
Questions? Call 787-848-9114
Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716
Package Label.Principal Display Panel
NDC 58552-322-01
PHENAGIL
ANTIHISTAMINE AND NASAL DECONGESTANT
SUGAR FREE AND DYE FREE
Each tablet contains:
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCI 10 mg
100 Tablets
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00716
4131-label (4131 Label)
* Please review the disclaimer below.
