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  5. Label Information: Pseudoephedrine Hydrochloride

FDA Label for Pseudoephedrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    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 ?
    14. PRINCIPAL DISPLAY PANEL

Pseudoephedrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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, USP 120 mg


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to:
    • •common cold
    • •hay fever
    • •upper respiratory allergies
    • •temporarily restores freer breathing through the nose
    • •promotes nasal and/or sinus drainage
    • •temporarily relieves sinus congestion and pressure

Warnings



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 a MAOI, ask a doctor or pharmacist before taking this product.


Ask A Doctor Before Use If You Have



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

When Using This Product



  • •do not use more than directed

Stop Use And Ask A Doctor If



  • •symptoms do not get better within 7 days or occur with a fever
  • •you get nervous, dizzy, or sleepless

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 Centre right away (1-800-222-1222)


Directions



  • •adults and children 12 years and older:
  • 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • •children under 12 years: ask a doctor

Other Information



  • •store at 59° to 77° F in a dry place
  • •protect from light
  • •TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients



castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide


Questions ?



call 1-800-406-7984


Principal Display Panel



NDC 70000-0164-1

Compare to Sudafed® 12 Hour active ingredient

Non-Drowsy Maximum Strength

12 Hour Nasal Decongestant

Pseudoephedrine Hydrochloride, 120 mg Long-Acting Nasal Decongestant Extended-Release Tablets, USP

12 Hour

Nasal & Sinus Congestion

due to Colds and Allergies

Sinus Pressure

10 COATED CAPSULE-SHAPED TABLETS 120 MG EACH


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