CERTI-SINE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CERTIFIED SAFETY MANUFACTURING]

  • Home
  • CERTI-SINE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CERTIFIED SAFETY MANUFACTURING]

CERTI-SINE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CERTIFIED SAFETY MANUFACTURING]
PDF | XML
NDC 48083-330-27, 48083-330-30, 48083-330-31, 48083-330-33, 48083-330-36, 48083-330-39, 48083-330-41
Set ID 6825b90f-133c-457d-b75b-4a630c0a2030
Category HUMAN OTC DRUG LABEL
Packager Certified Safety Manufacturing
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs