BALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]

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  • BALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]

BALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]
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NDC 63162-508-16, 63162-508-20
Set ID 9bae052a-2e3f-43c0-bf20-6f2cdf6f1ae5
Category HUMAN OTC DRUG LABEL
Packager Ballay Pharmaceuticals, Inc.
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)

    Chlorpheniramine Maleate, USP  2 mg

    Dextromethorphan HBr, USP  10 mg

    Phenylephrine HCl, USP  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 and over  2 teaspoonsful (10 mL) every 4 hours 
     children 6 years to under 12 years 1 teaspoonful (5 mL) every 4 hours
     children 2 years to under 6 years 1/2 teaspoonful (2.5 mL) every 4 hours
     children under 2 years 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 63162-508-16

    Balamine DM

                Syrup

    Antihistamine/Decongestant/

    Antitussive(Cough Suppressant)

    Each teaspoonful (5 mL) for oral

    administration contains:

    Chlorpheniramine

     Maleate .............................. 2 mg

    Dextromethorphan

     Hydrobromide ...................10 mg

    Phenylephrine

     Hydrochloride .....................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
    BALAMINE  DM SYRUP
    chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63162-508
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 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:63162-508-16473 mL in 1 BOTTLE
    2NDC:63162-508-206 in 1 TRAY
    220 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/23/2013
    Labeler - Ballay Pharmaceuticals, Inc. (035888200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ballay Pharmaceuticals, Inc.035888200manufacture(63162-508)
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