Label: CHILDRENS COLD AND COUGH- brompheniramine maleate, dextromethorphan, phenylephrine hcl liquid

  • NDC Code(s): 70000-0631-1
  • Packager: CARDINAL HEALTH 110, LLC. DBA LEADER
  • 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 March 30, 2023

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  • ACTIVE INGRADIENTS (in each 10 mL)

    Brompheniramine maleate, USP 2 mg

    Dextromethorphan HBr, USP 10  mg

    Phenylephrine HCl, USP 5 mg

  • PURPOSES

    Antihistamine

    Cough Suppressant

    Nasal decongestant

  • USES

    • temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • sneezing
    • Itching of the nose or throat
    • runny nose
    • itchy, watery eyes
    • temporarily restores freer breathing through the nose

  • WARNINGS

    .

  • DO NOT USE

    • to sedate a child or to make a child sleepy
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, or  psychiatric, 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
    • glaucoma
    • diabetes
    • thyroid disease
    • high blood pressure
    • difficulty in urination due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    • taking any other oral nasal decongestant or stimulant
    • taking sedative or tranquilizers
  • WHEN USING THIS PRODUCT

    • do not take more than directed
    • may cause drowsiness
    • alcohol, sedatives, and tranquillizers may increase drowsiness
    • avoid alcoholic beverages
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

  • STOP USE AND ASK A DOCTOR IF

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, 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 (1-800-222-1222) right away.

  • DIRECTIONS

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • do not exceed recommended dosage
    • mL = milliliter

                         Age               Dose  
     adults & children
     12 years & over 
    		 20 mL
    every 4 hours
     children 6 to under
     12 years
    		 10 mL
    every 4 hours
     children under 6 years do not use



  • OTHER INFORMATION

    • each 10 mL contains: sodium 10 mg
    • store at 20-25ºC (68-77ºF)
    • measuring cup provided
  • INACTIVE INGREDIENTS

    anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C Red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

  • QUESTIONS OR COMMENTS?

    call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est

  • PRINCIPAL DISPLAY PANEL

    LEADER

    NDC 70000-0631-1

    Children's Cold & Cough Liquid

    Brompheniramine Maleate

    Dextromethorphan Hydrobromide

    Phenylephrine Hydrochloride


    Antihistamine 

    Cough Suppressant

    Nasal Decongestant
    Grape 

    Flavor

    Relieves:

    Stuffy Nose,

    Runny Nose,

    Sneezing,

    Cough


    Alcohol-Free

    COMPARE TO CHILDREN'S DIMETAPP®

    COLD & COUGH

    active ingredients*


    4 FL OZ (118 mL)

           

    LDR_577_Crt

      

     

     

    ldr_577_lbl

        



  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND COUGH 
    brompheniramine maleate, dextromethorphan, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0631
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0631-11 in 1 CARTON03/30/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/30/2023
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70000-0631)
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