Label: GILTUSS ALLERGY PLUS- chlophedianol hcl, chlorpheniramine maleate, phenylephrine hcl tablet

  • NDC Code(s): 58552-334-20
  • Packager: Gil Pharmaceutical Corp
  • 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 January 21, 2023

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  • Drug Facts

    Active Ingredients (in each tablet)

    Chlophedianol HCl 24 mg

    Chlorpheniramine Maleate 3.5 mg

    Phenylephrine HCl 10 mg

  • PURPOSE

    Purposes

    Cough Suppressant

    Antihistamine

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves runny nose, sneezing, and itchy and watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.

  • WARNINGS

    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:

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • persistent or chronic cough such as occurs with smoking, asthma
    • chronic bronchitis, or emphysema
    • excessive phlegm (mucus)

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product:

    • do not exceed recommended dose
    • excitability may occur, especially in children
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if:

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not improve within 7 days or occur with a fever
    • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache

    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).

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and Children 12 years and over: Take 1 tablet every 6-8 hours. Do not take more than 4 tablets in a 24-hour period.
    • Children 6 to 12 years of age: Take 1/2 tablet every 6-8 hours. Do not take more than 2 tablets in a 24-hour period.
    • Children under 6 years: Consult a physician.
  • STORAGE AND HANDLING

    Other information

    • store at room temperature, USP
    • do not use if pouch is open or torn
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.

  • QUESTIONS

    Questions? Call 787-848-9114

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH

    Giltuss® ALLERGY PLUS

    COUGH & CONGESTION

    20 TABLETS

    SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

    Relieves

    • Sneezing
    • Runny Nose
    • Itchy & watery eyes
    • Double acting cough supressant
    • Stuffy Nose
    • Sinus Pressure

    58552-334 Allergy Plus Tabs 6-26-2018

  • INGREDIENTS AND APPEARANCE
    GILTUSS ALLERGY PLUS 
    chlophedianol hcl, chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-334
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE3.5 mg
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE24 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code GIL;323
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-334-2010 in 1 BOX04/01/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2021
    Labeler - Gil Pharmaceutical Corp (176826592)
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