Aprodine
FDA Label NDC 21695-929

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Aprodine (NDC 21695-929). 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(s), purpose, use(s), 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

Active Ingredient(S)

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

Purpose

Nasal decongestant

Antihistamine

Use(S)

  •  temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  •  runny nose
  •  itchy, watery eyes
  •  sneezing
  •  itching of the nose or throat
  •  temporarily relieves nasal congestion due to the common cold

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 rug. 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

  •  high blood pressure
  •  heart disease
  •  thyroid disease
  •  diabetes
  •  glaucoma
  •  a breathing problem such as emphysema or chronic bronchitis
  •  trouble urinating due to an enlarged prostate gland

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
  •  avoid alcoholic drinks
  •  alcohol, sedatives and tranquilizers may increase drowsiness
  •  be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  •  nervousness, dizziness or sleeplessness occur
  •  symptoms do not improve within 7 days or occur with a fever

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  •  adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  •  children under 12 years: do not use this product in children under 12 years of age

Other Information

  •  store at controlled room temperature 15°-30°C (59°-86°F)
  •  see end flap for expiration date and lot number

Inactive Ingredients

corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica gel, stearic acid, titanium dioxide

Questions Or Comments?

To Report Adverse Drug Event Call: (800) 616-2471

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Aprodine 60mg/2.5mg (E5e84aa0 A99d 47ae 983b Fc03f0f2c754 01)

Aprodine 60mg/2.5mg (E5e84aa0 A99d 47ae 983b Fc03f0f2c754 01)

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