Label: CHILDRENS MUCINEX MINI-MELTS CHEST CONGESTION- 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 June 17, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each packet)

    Guaifenesin 100 mg

  • Purpose

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • Warnings

    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 headache that lasts. These could be signs of a serious illness.

    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 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 1 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, banana flavor, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate, tutti-frutti flavor

  • Questions?

    1-866-682-4639

    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 63824-254-12

    Children's
    Mucinex
    ®

    Chest Congestion
    Guaifenesin 100 mg
    Expectorant

    mini•melts

    Age 4+

    Chest Congestion
    Breaks up Mucus

    Bubble Gum
    Flavor

    12 GRANULE PACKETS

    Principal Display Panel - 12 Packet Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCINEX   MINI-MELTS CHEST CONGESTION
    guaifenesin granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-254
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 form (UNII: K679OBS311)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    povidones (UNII: FZ989GH94E)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    sorbitol (UNII: 506T60A25R)  
    stearic acid (UNII: 4ELV7Z65AP)  
    talc (UNII: 7SEV7J4R1U)  
    triethyl citrate (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-254-1212 in 1 CARTON06/11/2012
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:63824-254-1818 in 1 CARTON08/01/2016
    2NDC:63824-254-022 in 1 CARTON
    21 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)