Phenagil
FDA Label NDC 66576-322

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Syntho Pharmaceuticals, Inc. for the product Phenagil (NDC 66576-322). 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, purposes, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before you use if you are taking sedatives or tranquilizers., stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

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.

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 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.

Directions

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

Other Information

• store at room temperature, USP.
• do not use if safety seal is broken or missing.

Inactive Ingredients

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

Questions? Call 787-848-9114

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- NDC- 66576-322-01- 100's Bottle Label.

Image Description (Phenagil D 100s Bottle Label)

Image Description (Phenagil D 100s Bottle Label)

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