Label: PRO-CHLO- chlophedianol hydrochloride, phenylephrine hydrochloride, pyrilamine maleate liquid

  • 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 November 16, 2011

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  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)
    Chlophedianol HCl 12.5 mg
    Phenylephrine HCl 5 mg
    Pyrilamine Maleate 12.5 mg

    Purpose

    Antitussive
    Nasal Decongestant
    Antihistamine
  • 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
    • nasal congestion
    • reduces swelling of nasal passages
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, water eyes
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • if you are now taking a prescription monoamine oxidase inhibibor (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)
    • 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

    Ask  a doctor or pharmacist 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
    • be careful when driving a motor vehicle or operating machinery

    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.  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 (10 mL)
    every 6 hours, not to
    exceed 8 teaspoonfuls in
    24 hours
    Children 6 to
    under 12 years
    of age:

    		1 teaspoonful (5 mL)
    every 6 hours, not to
    exceed 4 teaspoonfuls in
    24 hours
    Children under
    6 years of age:
    		Consult a doctor.

  • Other information

    Store at 59°-86°F (15°-30°C)
  • Inactive ingredients

    Bitter Mask, Citric Acid, Cotton Candy Flavor, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
  • Questions? Comments?

    Call 1-660-665-0084
  • Product Packaging

    The packaging below represents the labeling currently used:

    Principal display panel and side panel for 473 mL label:

    NDC #66594-321-16

    PRO-CHLO
    LIQUID

    ALCOHOL FREE·GLUTEN FREE·SUGAR FREE

    ANTITUSSIVE · NASAL DECONGESTANT
    · ANTIHISTAMINE

    Each teaspoonful (5 mL) contains:

    CHLOPHEDIANOL HCL...............................12.5 mg
    PHENYLEPHRINE HCL....................................5 mg
    PYRILAMINE MALEATE..............................12.5 mg

    Cotton Candy Flavor

    PATENT PENDING

    16 FL. OZ. (473 mL)

    PRO-PHARMA LLC

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

    Dispense in a tight, light-resistant container with a child-resistant
    cap.

    THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

    Patent Pending

    Manufactured by:
    Great Southern Laboratories,
    Houstin, TX  77099

    Distributed for:
    Pro-Pharma, LLC
    Kirksville, MO  63501

    Iss. 10/11
    PRO-CHLO LIQUID PACKAGING

    PRO-CHLO LIQUID PACKAGING





  • INGREDIENTS AND APPEARANCE
    PRO-CHLO 
    chlophedianol hydrochloride, phenylephrine hydrochloride, pyrilamine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66594-321
    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
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg  in 5 mL
    Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL) Pyrilamine Maleate12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66594-321-16473 mL in 1 BOTTLE
    2NDC:66594-321-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/12/2011
    Labeler - Pro-Pharma, LLC (781088146)
    Registrant - Great Southern Laboratories (056139553)
    Establishment
    NameAddressID/FEIBusiness Operations
    Great Southern Laboratories056139553manufacture
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