CHILDRENS MUCINEX STUFFY NOSE AND COLD (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]

  • Home
  • CHILDRENS MUCINEX STUFFY NOSE AND COLD (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]

CHILDRENS MUCINEX STUFFY NOSE AND COLD (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]
PDF | XML
NDC 63824-284-64
Set ID 8d0f2a01-f58b-43c0-b3f6-a88f9eb39c52
Category HUMAN OTC DRUG LABEL
Packager Reckitt Benckiser LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)Purposes
    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:
      • 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

    • your child gets nervous, dizzy or sleepless
    • 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 illness.

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

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • mL = milliliter
    AgeDose
    children 6 years to under 12 years10 mL every 4 hours
    children 4 years to under 6 years5 mL every 4 hours
    children under 4 yearsdo not use
  • Other information

    • each 5 mL contains: sodium 3 mg
    • tamper evident: do not use if neckband on bottle cap is broken or missing
    • store between 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, 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

    NDC 63824-284-64

    Children's
    Mucinex®

    Stuffy Nose &
    Cold

    Expectorant
    Nasal Decongestant

    Guaifenesin 100 mg
    Phenylephrine HCl 2.5 mg

    ✓
    Stuffy Nose
    ✓
    Chest Congestion
    ✓
    Breaks up Mucus

    Age 4+

    Mixed Berry
    Flavor Liquid

    4 FL OZ
    (118 mL)

    Principal Display Panel - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCINEX STUFFY NOSE AND COLD 
    guaifenesin and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-284
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    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
    ColorPINKScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-284-641 in 1 CARTON07/13/2012
    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 FINALpart34107/13/2012
    Labeler - Reckitt Benckiser LLC (094405024)
View All Sections

Related Drugs

Search DailyMed Drugs