CHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]

CHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]
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NDC 59779-886-24
Set ID fcbb0bb5-b5e9-47f6-a54f-114c9004ea47
Category Human OTC Drug Label
Packager CVS Pharmacy, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

    Active ingredients (in each 5 mL (1 tsp) dose)

    Guaifenesin, USP 100 mg
    Phenylephrine HCl, USP 2.5 mg



  • Purposes

    Expectorant
    Nasal 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. Avoid foods or beverages that contain caffeine.

  • 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 (1-800-222-1222).

  • Directions

    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • mL= milliliter; tsp = teaspoon
    Age
    Dose
    Children 6 years to 12 years
    10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
    Children 4 years to 6 years
    5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
    Children under 4 years
    do not use unless directed by a doctor
  • Other information

    • each 5 mL contains: sodium 3 mg
    • tamper evident: do not use if printed seal under cap is torn or missing
    • store at 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

  • Questions or Comments?

    1-855-274-4122

    You may also report side effects to this phone number.

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2015 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    Made in U.S.A.  V-32402

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

    CVS
    Health            NDC 59779-886-24

    Children's
    Stuffy Nose
    & Cold


    Each dose 5 mL (1 tsp) of
    oral solution contains:

    GUAIFENESIN, USP 100 mg
    Expectorant
    PHENYLEPHRINE HCl, USP 2.5 mg
    Nasal decongestant


    Relieves:

    • Stuffy nose
    • Chest congestion
    • Breaks up mucus

     Alcohol free

    For Ages 4+

    Mixed Berry Flavor Syrup
    Dosage cup included

    4 FL OZ (118 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    CHILDRENS STUFFY NOSE AND COLD 
    guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-886
    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)  
    MANGO (UNII: I629I3NR86)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (Pink to Red) Score    
    ShapeSize
    FlavorBERRY, MANGOImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-886-241 in 1 CARTON06/05/201503/01/2022
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/05/201503/01/2022
    Labeler - CVS Pharmacy, Inc. (062312574)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(59779-886)

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