GLENTUSS (DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) SYRUP [GLENDALE INC]

GLENTUSS (DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) SYRUP [GLENDALE INC]
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NDC 70147-233-16
Set ID 8a6eb670-8bed-4941-b4fd-70b3f1e48401
Category HUMAN OTC DRUG LABEL
Packager Glendale Inc
Generic Name
Product Class alpha-Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each teaspoonful)Purpose
    Dextromethorphan Hydrobromide 15 mgAntitussive (cough suppressant)
    Pseudoephedrine Hydrochloride 30 mgNasal Decongestant
    Doxylamine Succinate 6.25 mgAntihistamine
  • Uses

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

    • cough due to minor throat and bronchial irritation
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • temporarily restores freer breathing through the nose congestion
    • 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
    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occur with too much phlegm (mucus)

    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 4 dosage in a 24-hour period.

    Adults and children 12 years of age and over:2 teaspoonfuls every 6 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

    Apple candy flavor, citric acid, glycerin, 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 70147-0233-16

    Glentuss

    Antitussive
    Nasal Decongestant
    Antihistamine

    Each teaspoonful for oral
    administration contains:

    Dextromethorphan HBr 15 mg
    Pseudoephedrine HCl 30 mg
    Doxylamine Succinate 6.25 mg

    SUGAR FREE / DYE FREE
    ALCOHOL FREE

    Apple 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
    GLENTUSS 
    dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and doxylamine succinate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70147-233
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70147-233-16473 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)