Label: CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE liquid

  • NDC Code(s): 69367-183-16
  • Packager: Westminster Pharmaceuticals, LLC
  • 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 July 30, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL teaspoonful)Purpose
    Chlophedianol Hydrochloride 12.5 mgCough Suppressant
    Dexchlorpheniramine Maleate 1 mgAntihistamine
    Pseudoephedrine Hydrochloride 30 mgNasal Decongestant
  • 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
    • reduces congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exeed recommended dosage.

    Do not use this product

    • 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

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

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

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, diziness, 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. A persistent cough may be a sign of a serious condition.
    • new symptoms occur

    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 recommended dosage.

    adults and children 12 years of age and over:2 teaspoonfuls every 6 hours, not to exeed 8 teaspoonfuls in 24 hours.
    children 6 to under 12 years of age:1 teaspoonful every 6 hours, not to exeed 4 teaspoonfuls in 24 hours.
    children under 6 years of age:consult a doctor
  • Other Information

    • Store at room temperature 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)
  • Inactive ingredients

    citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

  • Questions or Comments?

    Call weekdays from 9 AM to 5 PM EST at 1-844-7294. You may also report serious side effects to this phone number.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 69367-183-16

    Chlophedianol HCl,
    Dexchlorpheniramine
    Maleate and
    Pseudoephedrine HCl

    Cough Suppressant
    Antihistamine
    Nasal Decongestant

    Sugar Free, Alcohol Free,
    Dye Free

    Tutti Frutti Flavor

    EACH 5 mL (1 TEASPOONFUL) CONTAINS:
    Chlophedianol Hydrochloride   12.5 mg
    Dexchlorpheniramine Maleate   1 mg
    Pseudoephedrine Hydrochloride   30 mg

    16 fl. oz. (473 mL)

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-183
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-183-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/29/2021
    Labeler - Westminster Pharmaceuticals, LLC (079516651)