Label: CHILDRENS MUCINEX NIGHT TIME MULTI-SYMPTOM COLD- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution

  • 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 September 6, 2016

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

  • SPL UNCLASSIFIED SECTION

    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

    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 drug 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 your 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 your child is

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

    When using this product

    • do not use more than directed
    • 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 for adults as well as for children 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)
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 days unless directed by a doctor
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • mL = milliliter
    • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; 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 between 20-25°C (68-77°F)
    • dosing cup provided
    • do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum


    1
    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: Reckitt Benckiser, Parsippany, NJ 07054-0224

    Made in England

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    New!

    NDC 63824-600-64

    Children's
    Mucinex
    ®

    NIGHT TIME

    Multi-Symptom
    Cold

    Pain Reliever/Fever Reducer
    Antihistamine/Cough Suppressant
    Nasal Decongestant

    Acetaminophen 325 mg
    Diphenhydramine HCl 12.5 mg
    Phenylephrine HCl 5 mg

    ✓ Stuffy Nose
    ✓ Cough
    ✓ Runny Nose & Sneezing
    ✓ Fever & Sore Throat

    Age 6+

    Mixed Berry
    Flavor Liquid

    4 FL OZ
    (118 mL)

    Principal Display Panel - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCINEX   NIGHT TIME MULTI-SYMPTOM COLD
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-600
    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)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propyl gallate (UNII: 8D4SNN7V92)  
    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:63824-600-64118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/25/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/25/2013
    Labeler - Reckitt Benckiser LLC (094405024)