Label: CONGESTAID II- phenylephrine hydrochloride tablet

  • NDC Code(s): 35418-334-02, 35418-334-67, 35418-334-68
  • Packager: Zee Medical Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 November 7, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient/Tablet Phenylephrine HCL 5 mg

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  • PURPOSE

    Purpose-Nasal Decongestant

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  • INDICATIONS & USAGE

    Temporarily relieves Nasal and sinus congestion due to: the common cold, hay fever, upper respiratory allergies

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  • DOSAGE & ADMINISTRATION

    Adults: Take 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours

    Children under 12 years, ask a doctor


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  • WARNINGS

    •    Warnings:
    •    Do not use:
    •    more than the recommended dose
    •    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 MAOI drug. If you do not know if your prescription 
    drug contains an MAOI, consult a doctor or pharmacist before 
    taking this product
    Stop use and ask a doctor if:
    •    symptoms do not improve
    •    new symptoms occur
    •    redness or swelling is present
    •    nervousness, dizziness or sleeplessness occur
    •    symptoms do not improve within 7 days or are accompanied by 
    fever
    Ask a doctor before use if you have:
    •    heart disease
    •    high blood pressure
    •    thyroid disease
    •    diabetes
    •    difficulty in urination due to enlargement of the prostate gland

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional  
    before use

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of overdose,  
    get medical help or contact a Poison Control Center right away.  
    Prompt medical attention is critical for adults as well as for  
    children even if you do not notice any signs or symptoms.

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Crosscarmellose Sodium,  DC Red 27, Dicalcium Phosphate, Hypromellose, Magnesium Stearate,
    Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Silicon Dioxide, Starch, Stearic Acid

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  • INGREDIENTS AND APPEARANCE
    CONGESTAID II 
    phenylephrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-334
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color white (snow white) Score no score
    Shape ROUND (ZEE;CAII) Size 6mm
    Flavor Imprint Code ZEE;CAII
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-334-68 50 in 1 CARTON 06/12/2012
    1 NDC:35418-334-67 125 in 1 CARTON
    1 NDC:35418-334-02 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(35418-334)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(35418-334)
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