Label: ALDEX D- phenylephrine hydrochloride and pyrilamine maleate suspension 

  • Label RSS
  • NDC Code(s): 65224-550-16
  • Packager: Pernix Therapeutics, LLC
  • 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 03/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each 5mL) Purpose
    Pyrilamine Maleate 16 mg Antihistamine
    Phenylephrine HCl 5 mg Nasal Decongestant
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  • Uses

    temporarily relieves

    • runny nose

    relieves

    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever or other upper respiratory allergies
    • nasal congestion due to the common cold
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  • Warnings

    • may cause excitability, especially in children

    • 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

    • heart disease
    • diabetes
    • thyroid disease
    • high blood pressure
    • glaucoma
    • a breathing problem such as emphysema, chronic bronchitis, or asthma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use

    • If you or your child are taking sedatives or tranquilizers

    When using this product

    • Do not exceed recommended dosage.
    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • if symptoms do not improve within 7 days or are accompanied by 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. 800-222-1222

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  • Directions

    • take every 6 hours
    • do not take more than 4 doses in 24 hours or as directed by a doctor
    Adults and children 12 years of age and older 1 to 2 teaspoonsful
    Children 6 to under 12 years of age 1 teaspoonful
    Children under 6 years of age Ask a doctor
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  • Other Information

    store at controlled room temperature 20°-25°C (68°-77°F)

    • Tamper Evident: Do not use if seal is broken or missing.
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  • Inactive ingredients

    Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sodium saccharin, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate.

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  • Questions?

    Call 1-800-793-2145

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  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 65224-550-16

    PERNIX
    THERAPEUTICS

    ALDEX® D

    Antihistamine/Decongestant
    (Pyrilamine/Phenylephrine)

    Grape flavored suspension

    Shake well

    16 fl. oz. (473 mL)

    Principal Display Panel - 473 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ALDEX D 
    phenylephrine hydrochloride and pyrilamine maleate suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65224-550
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
    PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 16 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GLYCERIN  
    GRAPE  
    MAGNESIUM ALUMINUM SILICATE  
    METHYLPARABEN  
    WATER  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    SODIUM CITRATE  
    SUCROSE  
    XANTHAN GUM  
    TANNIC ACID  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65224-550-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 06/01/2010
    Labeler - Pernix Therapeutics, LLC (004672296)
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