CLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]

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  • CLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]

CLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]
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NDC 49963-630-04, 49963-630-15
Set ID 49370e61-f9db-47d0-a43f-b1797b077867
Category HUMAN OTC DRUG LABEL
Packager Portal Pharmaceutical
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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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