Label: CLOPHED- chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride 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 December 30, 2010

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  • Drug Facts

    Active ingredients                                                      
    (in each 5 mL teaspoonful)
    Chlophedianol Hydrochloride 12.5 mg
    Guaifenesin 100 mg
    Phenylephrine Hydrochloride 5 mg

    Cough Suppressant
    Expectorant
    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
    • helps loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of the 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 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

    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.  These could be signs 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 accidental overdose, seek professional help or contact a Poison Control Center immediately.
  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:
    		2 teaspoonfuls every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period
    Children 6 to under 12 years of age:
    		1 teaspoonful every 6 to 8 hours, not to exceed 4 teaspoonfuls in a 24 hour period
    Children under 6 years of age
    		Consult a doctor

  • Other information

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

    Citric Acid, Glycerin, Orange Vanilla Flavor, propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol.
  • Questions? Comments?

    Call 1-787-832-6645
    Serious side effects associated with this product may be reported to this number.
  • Product Packaging:

    Packaging below represents the labeling currently used:

    Principal display panel and side panel for 118 mL label:

    NDC 49963-630-04

    Clophed

    Each teaspoonful (5 mL) for oral administration contains:
    Chlophedianol HCl.....................................12.5 mg
    Guaifenesin...............................................100 mg
    Phenylephrine HCl.........................................5 mg

    Cough Suppressant/Expectorant/Nasal Decongestant

    Alcohol Free/Dye Free/Gluten Free/Sugar Free

    4 fl oz (118 mL)

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

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

    See package insert for full prescribing information.

    Manufactured for:
    Portal Pharmaceutical
    Mayaguez, PR  00680                                Rev. 10/09



    Clophed Packaging



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  • INGREDIENTS AND APPEARANCE
    CLOPHED 
    chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-630
    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
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 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
    FlavorORANGE, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49963-630-04118 mL in 1 BOTTLE
    2NDC:49963-630-1515 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/28/2010
    Labeler - Portal Pharmaceutical (831005199)
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