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  5. Label Information: Childrens Uniphed Nasal Decongestant

FDA Label for Childrens Uniphed Nasal Decongestant

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML** 5 ML = ONE TEASPOONFUL)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS

Childrens Uniphed Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical 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.

Other



Drug Facts


Active Ingredient (In Each 5 Ml** 5 Ml = One Teaspoonful)



Pseudoephedrine HCl, USP 15 mg


Purpose



Nasal Decongestant


Uses



  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis
  • temporarily relieves sinus congestion and pressure
  • promotes nasal and/or sinus drainage

Otc - Do Not Use



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 giving 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 use more than directed


Stop Use And Ask A Doctor If



  • you get nervous, dizzy, or sleepness
  • symptoms do not improve within 7 days or are accompanied by fever

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 right away


Directions



  • take every 4 to 6 hours
  • do not take more than 4 doses in 24 hours
    • children under 2 years of ageask a doctor
    children 2 to under 6 years of ageone (1) teaspoonful
    children 6 to under 12 years of agetwo (2) teaspoonfuls
    adults and children 12 years of age and overfour (4) teaspoonfuls

Other Information



  • TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 4 mg
  • Store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients



citric acid, edetate disodium, FD&C Red #40, FD&C blue #1, flavor, glycerin, poloxamer, polyethylene glycol, povidone K-90, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, and water


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