Label: CODITUSSIN DAC- codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride syrup

  • 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 May 10, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each teaspoonful)Purpose
    *
    (Warning: May be habit-forming)
    Codeine Phosphate* 10 mgAntitussive (cough suppressant)
    Guaifenesin 200 mgExpectorant
    PseudoephedrineHydrochloride 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
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • reduces swelling of nasal passages
  • 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, chronic bronchitis 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

    When using this product

    • may cause or aggravate constipation

    Stop use and ask a doctor if

    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition
    • nervousness, dizziness, or sleeplessness occur
    • new symptoms occur

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental 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 4 to 6 hours, not to exceed 8 teaspoons in a 24 hour period
    Children 6 to under 12 years of age:1 teaspoonfuls every 4 to 6 hours, not to exceed 8 teaspoons in a 24 hour period
    *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) [see USP for Controlled Room Temperature]

  • Inactive ingredients

    Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

  • Questions? Comments?

    To report a serious adverse event or obtain product information, Call 1-630-530-7000.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Glendale Inc
    Villa Park, IL 60181

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 70147-414-16

    Coditussin
    DAC

    Expectorant
    Cough Suppressant
    Nasal Decongestant

    CV

    Each teaspoonful for oral
    administration contains:

    Codeine Phosphate* 10 mg
    *(Warning: May be habit-forming)

    Guaifenesin 200 mg

    Pseudoephedrine HCl 30 mg

    SUGAR FREE / DYE FREE
    ALCOHOL FREE / GLUTEN FREE

    Grape Flavored Liquid

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

    Distributed by:

    Glendale Inc

    Villa Park, IL 60181

    16 fl oz. (473 mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CODITUSSIN DAC 
    codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70147-414
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70147-414-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/01/2016
    Labeler - Glendale Inc (079987961)
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