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

Drug Label Information

Updated December 16, 2024

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

  • 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 DrugM01203/30/2023
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70000-0631)