Label: BALAHIST DM SYRUP- brompheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide 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 November 11, 2013

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  • Drug Facts

  • Active Ingredients (in each 5 mL teaspoonful)

    Brompheniramine Maleate, USP  4 mg

    Dextromethorphan HBr, USP  15 mg

    Phenylephrine HCl, USP  7.5 mg

    Purposes

     Chlorpheniramine Maleate Antihistamine
     Dextromethorphan HBr Cough Suppressant
     Phenylephrine HCl Nasal Decongestant

  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:

    • runny nose
    • nasal congestion
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • relieves cough associated with the common cold
  • Warnings

    Do not use

    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem, or persistent or chronic cough such as occurs with smoking, asthma, emphysema or chronic bronchitis
    • cough accompanied by excessive phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland.

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • Do not exceed recommended dosage
    • excitability may occur, especially in children
    • marked drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages.

    Stop use and ask a doctor if

    • new symptoms occur
    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    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 6 doses in a 24 hour period
     adults and children 12 years of age and over  1 teaspoonful (5 mL) every 4 to 6 hours 
     children 6 years to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours
     children under 6 years of age ask a doctor

  • Other information

    • do not use if tamper evident seal under cap is broken or missing
    • store between 20° - 25° C (68° - 77° F).
  • Inactive Ingredients

    citric acid, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, strawberry flavor.

  • Questions?

    call 1-800-847-1921

  • Manufactured by:

    Ballay Pharmaceuticals, Inc.

    Wimberley, Texas 78676

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 63162-520-16

    Balahist DM

    Syrup

    Antihistamine/Decongestant/

    Antitussive(Cough Suppressant)

    Each teaspoonful (5 mL) for oral

    administration contains:

    Brompheniramine

    Maleate .............................. 4 mg

    Dextromethorphan

    Hydrobromide .................... 15 mg

    Phenylephrine

    Hydrochloride ................... 7.5 mg


    For Professional Use Only

    Sugar Free/Alcohol Free/

    Dye Free

    BALLAY           16 fl oz.(473 mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    BALAHIST  DM SYRUP
    brompheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63162-520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63162-520-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/06/2014
    Labeler - Ballay Pharmaceuticals, Inc. (035888200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ballay Pharmaceuticals, Inc.035888200manufacture(63162-520)
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