Label: BICLORA- chlophedianol hydrochloride, chlorcyclizine hydrochloride liquid

  • 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 January 2, 2013

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)

    Chlophedianol Hydrochloride 12.5 mg
    Chlorcyclizine Hydrochloride 12.5 mg


  • 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
    • calms the cough control center and relieves coughing
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery 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)
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to the enlargement of the prostate gland

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

    When using this product

    • 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

    • 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

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.
  • Directions

    Do not exceed recommended dosage.
    Use a calibrated measuring device for administering the drug to a child.
    Adults and children
    12 years of age
    and over:
    2 teaspoonfuls (10 mL) every 6 to 8 hours,
    not to exceed 6 teaspoonfuls in 24 hours,
    or as directed by a doctor.
    Children 6 to under
    12 years of age:
    1 teaspoonful (5 mL) every 6 to 8 hours,
    not to exceed 3 teaspoonfuls in 24 hours,
    or as directed by a doctor.
    Children under
    6 years of age:
    Consult a doctor.

  • Other information

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).
    [See USP Controlled Room Temperature].
  • Inactive ingredients

    Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralsoe.
  • Questions? Comments?

    To report a serious adverse event or obtain product information, contact

    Manufactured for:
    Hawthorn Pharmaceuticals,
    Madison, MS  39110
    HI282 Rev. 12/11
  • Product Packaging

    The packaging below represents the labeling currently used.

    Principal display panel for 8 fl oz. label:

    NDC 54868-6381-0

    biclora Liquid Packaging

    biclora LIQUID

    Antitusive · Antihistamine

    Each teaspoonful (5 mL) contains:
    Chlophedianol HCl.......................12.5 mg
    Chlorcyclizine HCl.......................12.5 mg

    For professional use.
    The labeling for this product includes professional labeling
    which is not intended for use by the general public.

    Patent Pending

    Alcohol Free · Dye Free

    Cherry Flavor


    8 fl oz (240 mL)

    Distributed by:
    Physicians Total Care, Inc.
    Tulsa, OK        74146
    chlophedianol hydrochloride, chlorcyclizine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6381(NDC:63717-331)
    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
    Chlorcyclizine Hydrochloride (UNII: NPB7A7874U) (Chlorcyclizine - UNII:M26C4IP44P) Chlorcyclizine Hydrochloride12.5 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)  
    Sorbitol (UNII: 506T60A25R)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    FlavorCHERRYImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-6381-0240 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/02/2013
    Labeler - Physicians Total Care, Inc. (194123980)
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-6381)