Label: CERTI-SINE- phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 12, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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.
  • 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 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.

    Keep out of the reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Do not exceed recommended dosage.

  • 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

    • Nasal
      Decongestant
    Principal Display Panel - 5 mg Tablet Pouch Box
  • INGREDIENTS AND APPEARANCE
    CERTI-SINE 
    phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48083-330
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48083-330-2725 in 1 BOX12/29/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:48083-330-3050 in 1 BOX12/29/2017
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:48083-330-33125 in 1 BOX12/29/2017
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:48083-330-36250 in 1 BOX12/29/2017
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:48083-330-39500 in 1 BOX12/29/2017
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:48083-330-411000 in 1 BOX12/29/2017
    62 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:48083-330-3150 in 1 BOX12/29/2017
    72 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/29/2017
    Labeler - Certified Safety Manufacturing (788460483)
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