Label: PRO-CLEAR AC- codeine phosphate and pyrilamine maleate syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • 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 2, 2011

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  • Drug Facts

    Active ingredients                           
    (in each 5 mL teaspoonful)
    Codeine Phosphate* 9 mg
    *WARNING: May be habit forming.
    Pyrilamine Maleate 8.33 mg

    Purpose

    Antitussive
    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
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, water eyes
  • Warnings


    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)
    • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

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

    When using this product

    • may cause or aggravate constipation
    • 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

    • a cough 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 4 hours, not to
    exceed 6 doses in 24 hours.
    Children 6
    to under 12
    years of age:
    		1 teaspoonful (5 mL)
    every 4 hours, not to
    exceed 6 doses in 24 hours
    Children
    under 6
    years of age:
    		Consult a doctor.
    A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.  Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
  • Other information

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

    Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
  • Questions? Comments?

    Serious side effects associated with use of this product may be reported to this number.  Call 1-660-665-0084 (8 a.m. to 5 p.m.)

    CV
  • Product Packaging:

    The packaging below represents the labeling currently used.

    Principal display panel and side panel for 473 mL label:

    NDC # 66594-333-16            

     CV

    PRO-CLEAR AC
    SYRUP

    SUGAR FREE · DYE FREE · ALCOHOL FREE · GLUTEN FREE

    ANTITISSIVE · ANTIHISTAMINE

    Each teaspoonful (5 mL) contains:
    CODEINE PHOSPHATE*.............................9 mg
    *(WARNING: MAY BE HABIT-FORMING)
    PYRILAMINE MALEATE..........................8.33 mg

    Cotton Candy Flavor

    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.

    Manufactured by:
    Great Southern Laboratories,
    Houston, TX  77099

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

    Rev. 10/11

    PRO-CLEAR AC SYRUP Packaging


    PRO-CLEAR AC SYRUP Packaging



  • INGREDIENTS AND APPEARANCE
    PRO-CLEAR  AC
    codeine phosphate and pyrilamine maleate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66594-333
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate9 mg  in 5 mL
    Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL) Pyrilamine Maleate8.33 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid (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:66594-333-0130 mL in 1 BOTTLE
    2NDC:66594-333-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/08/2008
    Labeler - Pro-Pharma LLC (781088146)
    Registrant - Great Southern Laboratories (056139553)
    Establishment
    NameAddressID/FEIBusiness Operations
    Great Southern Laboratories056139553manufacture
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