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  5. Label Information: Pseudoephedrine Hcl

FDA Label for Pseudoephedrine Hcl

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. QUESTIONS OR COMMENTS? 1-888-462-4166
    9. PRODUCT LABEL

Pseudoephedrine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Innovida Pharmaeutique Corporation. 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 (In Each Tablet)



Pseudoephedrine HCl 30 mg


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies 
  • temporarily restores freer breathing through the nose

Warnings



Do not useif 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

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

    • 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

      • 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 older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
 children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
 children under 6 years do not use


Other Information



  • Store in a dry place at 15°-30°C (59°-86°F) 

Inactive Ingredients



calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide


Questions Or Comments? 1-888-462-4166




Product Label



image description - image 54

image description - image 54


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