Label: CHILDRENS MUCINEX MINI-MELTS COUGH- dextromethorphan hydrobromide and guaifenesin granule

  • 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 November 14, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purpose
    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 due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help you get to sleep
  • 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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    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 illness.

    If pregnant or breast-feeding, ask a healthcare 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 take more than 6 doses in any 24-hour period
    AgeDose
    adults and children 12 years and over2 to 4 packets every 4 hours
    children 6 years to under 12 years1 to 2 packets every 4 hours
    children 4 years to under 6 years1 packet every 4 hours
    children under 4 yearsdo not use
  • Other information

    • each packet contains: magnesium 6 mg and sodium 3 mg
    • phenylketonurics: contains phenylalanine 2 mg per packet
    • store between 20-25°C (68-77°F)
    • tamper evident: do not use if carton is open or if packets are torn or open
  • Inactive ingredients

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

  • Questions?

    1-866-MUCINEX(682-4639)
    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 12 Packet Carton

    NDC 63824-256-12

    Children's
    Mucinex
    ®

    Cough
    Expectorant
    Cough Suppressant

    Guaifenesin 100 mg / Dextromethorphan HBr 5 mg

    mini-melts

    ✓ Cough
    ✓ Chest Congestion
    ✓ Breaks up Mucus

    Orange Creme
    Flavor

    12 GRANULE PACKETS

    Principal Display Panel - 12 Packet Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCINEX   MINI-MELTS COUGH
    dextromethorphan hydrobromide and guaifenesin granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-256
    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)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    povidones (UNII: FZ989GH94E)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    carboxymethylcellulose sodium (UNII: K679OBS311)  
    sorbitol (UNII: 506T60A25R)  
    stearic acid (UNII: 4ELV7Z65AP)  
    talc (UNII: 7SEV7J4R1U)  
    triethyl citrate (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorORANGE (Orange Crème) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-256-1212 in 1 CARTON
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Finalpart34103/24/2009
    Labeler - Reckitt Benckiser (094405024)