Label: CHLO HIST- chlophedianol hydrochloride, dexbrompheniramine maleate 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 January 16, 2019

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  • Drug Facts

    Active ingredients

    (in each 5 mL teaspoonful)

    Chlophedianol Hydrochloride 12.5 mg

    Dexbrompheniramine Maleate 1 mg

    Purpose

    Cough Suppressant

    Antihistamine

  • INDICATIONS & USAGE

    Uses A nonnaracotic cough suppressant and antihistamine for the temporary relief of:

    • cough due to minor throat and bronchial irritation
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • Warnings

    Do not exceed recommended dosage.

    • May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.  Use caution when diving a motor vehicle or operating machinery.

    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
    • trouble urinating due to an enlarged 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 tranquilizes may increase the drowsiness effect
    • be careful when driving a motor vehicle or operating machinery

    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. 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 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 over:
    		2 teaspoonfuls (10 mL)
    every 6 hours, not to
    exceed 4 doses 
    in 24 hours
    Children 6 to under
    12 years of age:


    		1  teaspoonful
    (5 mL) every 6 hours,
    not to exceed 4
    doses in
    24 hours
    Children under 6
    years of age:     		Consult a Physician.

  • Other information

    Store at 59°-86°F (15°-30°C)

  • Inactive ingredients

    Citric Acid, Glycerin, Grape Flavor, 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.  Call 1-423-493-9170 (8 a.m. to 5 p.m.)

  • Chlophedianol Hydrochloride, Dexbrompheniramine Maleate

    Label Image
  • INGREDIENTS AND APPEARANCE
    CHLO HIST 
    chlophedianol hydrochloride, dexbrompheniramine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3998(NDC:12830-864)
    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
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3998-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product12/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/15/2014
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3998)
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