Home > Drugs A-Z > Nasal Decongestant

Nasal Decongestant (Bryant Ranch Prepack)

Available Formats

Dosage Form Package Information Links
TABLET, SUGAR COATED 14 TABLET, SUGAR COATED in 1 BOTTLE (63629-2625-3) Label Information
TABLET, SUGAR COATED 24 TABLET, SUGAR COATED in 1 BOTTLE (63629-2625-2) Label Information
TABLET, SUGAR COATED 30 TABLET, SUGAR COATED in 1 BOTTLE (63629-2625-1) Label Information

Complete Nasal Decongestant Information

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Pseudoephedrine HCl 30 mg

  • PURPOSE

    Purpose
    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses
    • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
    • temporarily restores freer breathing through the nose

  • WARNINGS

    Warnings

  • DO NOT USE

    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 doctor or pharmacist before taking this product.

  • ASK DOCTOR

    Ask a doctor before use if you have
    • high blood pressure
    • heart disease
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

  • WHEN USING

    When using this product
    • do not use more than directed

  • STOP USE

    Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless
    • symptoms do not improve within 7 days or accompanied by fever

  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    • take every 4-6 hours
    • do not take more than 4 doses in 24 hours
    adults and children 12 years and over: 2 tablets
    children 6 to under 12 years: 1 tablet
    children under 6 years: do not use

  • STORAGE AND HANDLING

    Other information
    • store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F)
    • protect from light

  • INACTIVE INGREDIENT

    Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D-C red #27 aluminum lake, D-C yellow #10 aluminum lake, FD-C red #40 aluminum lake, FD-C yellow #6 aluminum lake, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre), kaolin, microcrystalline cellulose, polyethylene glycol (PEG) - 400, pregelatinized starch, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

  • QUESTIONS

    Questions or comments? call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
  • PRINCIPAL DISPLAY PANEL

    Pseudoephedrine HCL 30 mg Tablet

    Label

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hcl tablet, sugar coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-2625(NDC:0536-4391)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color red Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code TCL;016
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-2625-1 30 in 1 BOTTLE
    2 NDC:63629-2625-2 24 in 1 BOTTLE
    3 NDC:63629-2625-3 14 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/22/2011
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-2625) , RELABEL(63629-2625)