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  5. Label Information: Aprodine

FDA Label for Aprodine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Aprodine Product Label

The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Principal Display Panel



Aprodine 60mg/2.5mg - e5e84aa0 a99d 47ae 983b fc03f0f2c754 01

Aprodine 60mg/2.5mg - e5e84aa0 a99d 47ae 983b fc03f0f2c754 01


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