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
  • 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 31, 2022

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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 use if 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 if cough 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 mg and 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 FINALpart34101/27/2022
    Labeler - RB Health (US) LLC (081049410)
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