Label: MUCINEX CHILDRENS COUGH AND CHEST CONGESTION MINI-MELTS ORANGE CREME- dextromethorphan hydrobromide and guaifenesin granule

  • NDC Code(s): 63824-943-02, 63824-943-12
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purposes
    Dextromethorphan HBr 5 mgCough suppressant
    Guaifenesin 100 mgExpectorant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves cough as may occur with a cold.
  • Warnings

    Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or 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

    • persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)

    When using this product do not use more than directed

    Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with 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

    • empty entire contents of packet onto tongue and swallow
    • for best taste, do not chew granules
    • do not give more than 6 doses in any 24-hour period
    • dose as follows or as directed by a doctor
    AgeDose
    adults and Children 12 years of age and over2 to 4 packets every 4 hours
    children 6 years to under 12 years of age1 to 2 packets every 4 hours
    children 4 years to under 6 years of age1 packet every 4 hours
    children under 4 years of agedo not use
  • Other information

    • each packet contains: magnesium 6 mgand sodium 3 mg
    • phenylketonurics: contains phenylalanine 2 mg per packet
    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate

  • Questions?

    1-866-682-4639

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. By: RB Health (US)
    Parsippany, NJ 07054-0224

    Made in Germany

  • PRINCIPAL DISPLAY PANEL - 12 Packet Carton

    Pediatrician Recommended*

    NDC 63824-943-12

    Mucinex®
    children's

    COUGH AND
    CHEST CONGESTION

    Dextromethorphan HBr 5 mg - Cough Suppressant
    Guaifenesin 100 mg - Expectorant

    • Controls Cough
    • Relieves Chest Congestion
    • Thins and Loosens Mucus

    Ages
    4 +years

    Orange Crème
    Flavor

    12 GRANULE PACKETS

    PRINCIPAL DISPLAY PANEL - 12 Packet Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX CHILDRENS  COUGH AND CHEST CONGESTION MINI-MELTS ORANGE CREME
    dextromethorphan hydrobromide and guaifenesin granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-943
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-943-1212 in 1 CARTON01/27/2022
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:63824-943-022 in 1 PACKAGE01/27/2022
    21 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/27/2022
    Labeler - RB Health (US) LLC (081049410)
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