Label: GLEN PE- phenylephrine hydrochloride and pyrilamine maleate syrup

  • 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 9, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each teaspoonful)Purpose
    Pyrilamine Maleate 16 mgAntihistamine
    Phenylephrine Hydrochloride 5 mgNasal Decongestant
  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • temporarily restores freer breathing through the nose
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • to sedate a child or make a child sleepy
    • 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
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    • taking any other nasal decongestant or stimulant
    • taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

    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.

  • Directions

    Do not exceed 6 dosage in a 24-hour period.

    Adults and children 12 years of age and over:2 teaspoonfuls every 4 hours
    Children under 12 years of age:Consult a physician
  • Other information

    Store at 59°-86°F (15°-30°C) [see USP for Controlled Room Temperature]

  • Inactive ingredients

    Citric acid, cotton candy flavor, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.

  • Questions? Comments?

    To report a serious adverse event or obtain product information, Call 1-630-530-7000.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Glendale Inc
    Villa Park, IL 60181

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 70147-0224-16

    Glen PE

    Antihistamine
    Nasal Decongestant

    Each teaspoonful for oral
    administration contains:
    Pyrilamine Maleate 16 mg
    Phenylephrine HCl 5 mg

    SUGAR FREE /
    ALCOHOL FREE

    Cotton Candy Flavored Liquid

    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or missing.

    Distributed by:
    Glendale Inc
    Villa Park, IL 60181

    16 fl oz. (473 mL)

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    GLEN PE 
    phenylephrine hydrochloride and pyrilamine maleate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70147-224
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE15 mg  in 5 mL
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE16 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70147-224-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/05/2015
    Labeler - Glendale Inc (079987961)
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