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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. 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?
    14. PRINCIPAL DISPLAY PANEL

Pseudoephedrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. 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

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
  • •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 Center right away.


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

Keep the carton. It contains important information.

See end panel for expiration date.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431


Principal Display Panel



Premier Value®

NDC 68016-204-69

Pseudoephedrine HCl Extended-Release Tablets USP, 120 mg

Sinus & Allergy

Long-Acting Nasal Decongestant

Non-Drowsy

12 Hour

  • •Nasal & Sinus Congestion due to Colds & Allergies
  • •Sinus Pressure
  • •Maximum Strength

    • 10 Coated Capsule-Shaped Tablets 120 mg Each

    †Compare to the active ingredient in Sudafed®12 Hour

    †This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark SUDAFED®12 Hour.


* Please review the disclaimer below.