Phenylephrine Hydrochloride Tablet
FDA Label NDC 83586-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hhh Pharmaceuticals for the product Phenylephrine Hydrochloride (NDC 83586-010). 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 active ingredient (in each caplet), purpose, uses, warnings, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Phenylephrine HCl USP 10 mg

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves 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.

Otc - When Using

When using this product do not exceed recommended dose.

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away.

Directions

  • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: ask a doctor

Other Information

  • each tablet contains: phosphorus 10 mg
  • store at controlled room temperature between 20°-25°C (68°-77°F)
  • protect from excessive moisture
  • read all product information before using

Inactive Ingredients

Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose

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