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

Mucinex Childrens by

Drug Labeling and Warnings

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

  • SPL UNCLASSIFIED SECTION

    Night Time Multi-Symptom Cold – Ages 6+

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • runny nose
      • sneezing
      • cough
    • controls cough to help your child get to sleep
    • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if your child takes:

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on the skin
    • 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

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

    Ask a doctor or pharmacist before use if the child is

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed (see Overdose warning)
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see Overdose warning)
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period
    • children under 6 years of age: do not use
  • Other information

    • each 10 mL contains: sodium 6 mg
    • store at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C blue no. 1, 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

    VALUE
    PACK

    READ ALL INFORMATION

    NDC: 63824-955-74

    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

    4 FL OZ (118 mL)

    NIGHT TIME
    MULTI-SYMPTOM
    COLD

    Acetaminophen 325 mg – Pain Reliever/Fever Reducer
    Diphenhydramine HCl 12.5 mg – Antihistamine/Cough Suppressant
    Phenylephrine HCl 5 mg – Nasal Decongestant

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

    Ages
    6+
    yrs

    Very Berry
    Flavor Liquid

    4 FL OZ (118 mL)

    8 FL OZ (236 mL) TOTAL

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX CHILDRENS   DAY TIME MULTI-SYMPTOM COLD AND NIGHT TIME MULTI-SYMPTOM COLD
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, acetaminophen, and diphenhydramine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63824-955
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63824-955-741 in 1 CARTON01/21/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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
    1118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/21/2019
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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
    1118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/21/2019
    Labeler - RB Health (US) LLC (081049410)

  • © 2022 FDA.report
    This site is not affiliated with or endorsed by the FDA.