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  5. Label Information: Certi-sine

FDA Label for Certi-sine

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (EACH TABLET)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL - 5 MG TABLET POUCH BOX

Certi-sine Product Label

The following document was submitted to the FDA by the labeler of this product Certified Safety Manufacturing. 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

Do not exceed recommended dosage.


Active Ingredients (Each Tablet)



Phenylephrine HCl 5 mg


Purpose



Nasal decongestant


Uses



  • For the temporary relief of nasal congestion due to a cold, hay fever or other upper respiratory allergies associated with sinusitis.
  • Temporarily relieves stuffy nose, 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 health professional before taking this product.

Ask A Doctor Before Use If You Have



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

Stop Use And Ask A Doctor If



  • new symptoms occur
  • symptoms do not improve within 7 days
  • redness or swelling are present
  • you get nervous, dizzy or sleepless.

If Pregnant Or Breast-Feeding



  • ask a health professional before use.

Directions



  • Adults and children 12 years of age and older
Take 2 tablets every 4 hours as needed.
Do not take more than 12 tablets in 24 hours.
  • Children under 12 years of age
Do not use this adult strength product without first speaking to your doctor.

Other Information



  • read all product information before using
  • store at room temperature 59-86°F (15-30°C)
  • use by expiration date on package.

Inactive Ingredients



  • Colloidal silica, croscarmellose sodium, dicalcium phosphate, D & C Red #27 Lake, Magnesium Stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, stearic acid, talc.

Questions?



Call 1-800-854-7474


Principal Display Panel - 5 Mg Tablet Pouch Box



Tamper evident
packaging:
Do not use if
open or torn.

This package for
households
without children

See New Warnings
Information

Compare to Sudafed PE ®
CERTI-SINE™
5 mg Phenylephrine HCl

* Please review the disclaimer below.