Label: PRO-RED AC- codeine phosphate, dexchorpheniramine maleate, phenylephrine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL

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 October 7, 2013

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  • Drug Facts

    Active ingredients

    (in each 5 mL teaspoonful)

    Codeine Phosphate 9 mg

    *(WARNING:  MAY BE HABIT-FORMING)

    Dexchlorpheniramine Maleate 1 mg

    Phenylephrine Hydrochloride 5 mg

    Purpose

    Antitussive

    Antihistamine

    Nasal 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
    • nasal congestion
    • reduces swelling of nasal passages
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • Warnings

    Do not exceed 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)
    • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
    • 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

    • 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

    • 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 the 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 older:    		2 teaspoonfuls
    (10 mL) every
    4 hours, not to
    exceed 6 doses in a
    24 hours.

    Children 6

    to under 12

    years of age:

    		1 teaspoonful (5 mL)
    every 4 hours, not
    to exceed 6 doses
    in a 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, FD&C Red #40, 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.  1-660-665-0084

    (8 a.m. to 5 p.m.)

    CV

  • Product Packaging

    Principal display panel and side panel for 473 mL label:

    NDC #66594-499-16

    CV

    PRO-RED AC

    SYRUP

    ALCOHOL FREE / SUGAR FREE / GLUTEN FREE

    ANTITUSSIVE / ANTIHISTAMINE / NASAL DECONGESTANT

    Each teaspoonful (5 mL) contains:

    CODEINE PHOSPHATE...........................9 mg

    *(WARNING: MAY BE HABIT-FORMING)

    DEXCHLORPHENIRAMINE

    MALEATE...............................................1 mg

    PHENYLEPHRINE

    HYDROCHLORIDE..................................5 mg

    Cotton Candy Flavor

    16 FL. OZ. (473 mL)

    PRO-PHARMA LLC

    "NEW FORMULATION"

    Tamper evident by foil seal under cap.  Do not use

    if foil seal is broken or missing.

    THIS BOTTLE NOT TO BE DISPENSED TO CONSUMER.

    Dispense in a tight, light-resistant container with

    a child-resistant cap.

    Manufactured by:

    Pernix Manufacturing, LLC

    Houston, TX  77099

    Distributed for:

    Pro-Pharma, LLC

    Kirksville, MO  63501

    Rev. 09/13

    PRO-RED AC Packaging

    PRO-RED AC Packaging

  • INGREDIENTS AND APPEARANCE
    PRO-RED  AC
    codeine phosphate, dexchorpheniramine maleate, phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66594-499
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Codeine Phosphate (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) Codeine Phosphate9 mg  in 5 mL
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 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:66594-499-16473 mL in 1 BOTTLE
    2NDC:66594-499-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/30/2013
    Labeler - Pro-Pharma, LLC (781088146)
    Registrant - Pernix Manufacturing, LLC (078641814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(66594-499)
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