Label: PSEUDO TIME PE- phenylephrine hchloride tablet, film coated

  • NDC Code(s): 49483-234-00, 49483-234-18, 49483-234-36
  • Packager: TIME CAP LABORATORIES, 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 December 14, 2018

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  • ACTIVE INGREDIENT

    Each tablet contains: Phenylephrine HCl 10 mg

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: CARNAUBA WAX, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED#40 ALUMINUM LAKE, FD-C YELLOW#6 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL (PEG) 400, STEARIC ACID, TITANIUM DIOXIDE

  • KEEP OUT OF REACH OF CHILDREN

    keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

  • PURPOSE

    PURPOSE: nasal decongestant

  • INDICATIONS & USAGE

    Uses:

    Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis

    Temporarily relieves sinus congestion and pressure

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    Take every 4 hours; Do not take more than 6 doses in 24 hours; Adults and children 12 years of age and over; 1 tablet

    Children under 12 years of age; ask a doctor


  • WARNINGS

    WARNINGS;

    Do not use if you are 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.

  • PRINCIPAL DISPLAY PANEL

    234label

  • INGREDIENTS AND APPEARANCE
    PSEUDO TIME PE 
    phenylephrine hchloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code T234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-234-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product12/14/2018
    2NDC:49483-234-3636 in 1 BLISTER PACK; Type 0: Not a Combination Product12/14/2018
    3NDC:49483-234-00100000 in 1 CARTON; Type 0: Not a Combination Product12/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/14/2012
    Labeler - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(49483-234)
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