Label: NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet, film coated 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/11

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

  • Active ingredient(s)

    Phenylephrine HCl 10 mg

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  • Purpose

    Nasal decongestant

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  • Use(s)

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

    • temporarily relieves sinus congestion and pressure

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  • 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 doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • diabetes

    • heart disease

    • high blood pressure

    • thyroid disease

    • trouble urinating due to an enlarged prostate gland

    When using this product

    • do not exceed recommended dose

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur

    • symptoms do not improve within 7 days or occur with fever

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

    • children under 12 years: do not use this product in children under 12 years of age

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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)

    • see end flap for expiration date and lot number

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  • Inactive ingredients

    croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

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  • Questions

    1-800-426-9391

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  • Principal Display Panel

    The product packaging shown below represents a sample of that currently in use. Additional pakaging may also be available.

    DG™

    health

    Compare to active ingredient in Sudafed PE®*

    Maximum Strength

    Nasal Decongestant PE

    Phenylephrine HCl Tablets, 10 mg

    • Relieves Nasal & Sinus Congestion and Sinus Pressure

    •Non-Drowsy

    •1 Pill/Dose

    •Pseudoephedrine Free

    18

    Tablets

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    50844            REV0810E45344

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100% QUALITY GUARANTEED

    (888) 309-9030

    Product Packaging

    Product Packaging

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  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT PE 
    phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-453
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    DEXTROSE MONOHYDRATE  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
    FD&C RED NO. 40  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code 44;453
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-453-44 1 in 1 CARTON
    1 18 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/06/2004
    Labeler - DOLGENCORP, LLC (068331990)
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