Label: CHILDRENS METAPP DAYTIME- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl 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 January 13, 2022

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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 finalpart34106/06/2012
    Labeler - Guardian Drug Company (119210276)
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