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  5. Label Information: Zephrex D

FDA Label for Zephrex D

View Indications, Usage & Precautions

Table of Contents

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

Zephrex D Product Label

The following document was submitted to the FDA by the labeler of this product L. Perrigo Company. 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 Softgel)



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 relieves sinus congestion and pressure

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

When Using This Product



do not exceed recommended dosage


Stop Use And Ask A Doctor If



  • •nervousness, dizziness, or sleeplessness occurs
  • •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 (1-800-222-1222).


Directions



take 2 softgels every 4 to 6 hours
  • do not take more than 8 softgels in 24 hourstake 1 softgel every 4 to 6 hours
  • do not take more than 4 softgels in 24 hours

    adults and children 12 years and over

    ••

    children ages 6 to under 12 years

    ••

    children under 6 years

    do not use this product in children under 6 years of age


    Other Information



    • •store at 20-25°C (68-77°F)
    • •do not use if blister unit is broken or torn

    Inactive Ingredients



    croscarmellose sodium, FD&C red no. 40, gelatin, guar gum, hydroxypropylcellulose, lecithin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, sorbitan, sorbitol, titanium dioxide, vegetable oil, xanthan gum


    Questions Or Comments?



    1-800-719-9260


    Package/Label Principal Display Panel



    NEW DOSAGE FORM

    MAXIMUM STRENGTH

    ZEPHREX-D ®

    CONGESTION

    Pseudoephedrine HCl 30 mg

    Nasal Decongestant

    METH BLOCKING TAREX® TECHNOLOGY ™

    Non-Drowsy

    Relieves

    Nasal & Sinus Congestion

    Sinus Pressure

    Easy-to-take softgels.

    Individually sealed.

    Actual Size

    Fast-acting nasal decongestant goes to work in as little as 30 minutes. With advanced meth-blocking technology for safer communities.

    24 softgels


    * Please review the disclaimer below.