Label: CHILDRENS METAPP DAYTIME- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active ingredients (in each 5 mL tsp)

    Brompheniramine maleate 1 mg
    Dextromethorphan HBr 5 mg

    Phenylephrine HCl 2.5 mg

  • Purposes

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • KEEP OUT OF REACH OF CHILDREN

  • 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, psychiatric, or emotional conditions, or parkinsons 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
    • 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 sedatives or tranquilizers

    when using this product

    • do not take more than directed
    • may cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcohol beverages
    • be careful when driving a motor vehicle or operating mahcinery
    • 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 right away. 

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • do not exceed recommended dosage
     AgeDose 
     adults and children 12 years and over 4 tsp (20 mL) every 4 hours
     children 6 to under 12 years 2 tsp (10 mL) every 4 hours
     children under 6 years do not use

  • Other information

    • each teaspoon (tsp) contains: sodium 5 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, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

  • PDP

    Compare to the active ingredients in Childrens Dimetapp

    Childrens Metapp Daytime

    Cold & Cough

    Brompheniramine Maleate

    Antihistamine

    Dextromethorphan HBr

    Cough Suppressant

    Phenylephrine HCl

    Nasal Decongestant

    Relieves:

    • Nassal Congestion
    • Soothes Cough
    • Calms allergies

    Alcohol Free

    For ages 6 years and over

    Grape

    4 FL OZ (118 mL)

    SN

  • INGREDIENTS AND APPEARANCE
    CHILDRENS METAPP DAYTIME 
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-577
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 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)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-577-031 in 1 CARTON06/06/2012
    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 DrugM01206/06/2012
    Labeler - Guardian Drug Company (119210276)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(53041-577)
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