MUCINEX CHILDRENS DAY TIME MULTI-SYMPTOM COLD AND MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD TRIPLE PACK- acetaminophen, diphenylhydramine hydrochloride, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin kit

Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack by

Drug Labeling and Warnings

Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Questions?

    1-866-682-4639

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)Purposes
    Dextromethorphan HBr 5 mgCough suppressant
    Guaifenesin 100 mgExpectorant
    Phenylephrine HCl 2.5 mgNasal decongestant
  • 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 your child get to sleep
      • nasal congestion due to a cold
      • stuffy nose
  • Warnings

    Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma

    When using this product do not use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not get better within 7 days or occur with fever
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not give more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    AgeDose
    children 6 to under 12 years of age10 mL every 4 hours
    children 4 to under 6 years of age5 mL every 4 hours
    children under 4 years of agedo not use
  • Other information

    • each 5 mL contains: sodium 3 mg
    • store between 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate2, xanthan gum


  • 2 may contain this ingredient
  • Questions?

    1-866-MUCINEX (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 Mexico

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Pediatrician Recommended
    TRIPLE
    PACK

    NDC: 63824-944-34

    READ ALL INFORMATION

    Mucinex®
    Children's

    DAY TIME
    MULTI-SYMPTOM
    COLD

    Dextromethorphan HBr 5 mg - Cough Suppressant
    Guaifenesin 100 mg - Expectorant
    Phenylephrine HCl 2.5 mg - Nasal Decongestant

    • ✔ Relieves Stuffy Nose
    • ✔ Controls Cough
    • ✔ Relieves Chest Congestion
    • ✔ Breaks up Mucus

    Ages
    4+ yrs

    Very Berry
    Flavor Liquid

    THREE – 4 FL OZ (118mL)

    NIGHT TIME
    MULTI-SYMPTOM
    COLD

    Acetaminophen 325 mg–Pain Reliever/Fever Reducer
    Diphenhydramine HCl 12.5–Antihistamine/
    Cough Suppressant
    Phenylephrine HCl mg–Nasal Decongestant

    • ✔ Relieves Stuffy Nose
    • ✔ Controls Cough
    • ✔ Relieves Runny Nose & Sneezing
    • ✔ Relieves Fever & Sore Throat

    Ages
    6+ yrs

    Very Berry
    Flavor Liquid

    TOTAL – 12 FL OZ (354mL)

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX CHILDRENS DAY TIME MULTI-SYMPTOM COLD AND MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD TRIPLE PACK 
    acetaminophen, diphenylhydramine hydrochloride, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63824-944
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63824-944-341 in 1 CARTON05/25/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BOTTLE 236 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    MUCINEX CHILDRENS MULTI-SYMPTOM COLD 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride suspension
    Product Information
    Item Code (Source)NDC: 63824-949
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 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)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    propyl gallate (UNII: 8D4SNN7V92)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63824-949-011 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/30/2018
    Part 2 of 2
    MUCINEX CHILDRENS  NIGHT TIME MULTI-SYMPTOM COLD
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution
    Product Information
    Item Code (Source)NDC: 63824-950
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    propyl gallate (UNII: 8D4SNN7V92)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63824-950-211 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/25/2022
    Labeler - RB Health (US) LLC (081049410)

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