MULTI SYMPTOM COLD AND MULTI SYMPTOM NIGHTTIME COLD CHILDRENS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI) KIT [CVS PHARMACY]

MULTI SYMPTOM COLD AND MULTI SYMPTOM NIGHTTIME COLD CHILDRENS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI) KIT [CVS PHARMACY]
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NDC 69842-606-04, 69842-607-04, 69842-820-08
Set ID ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients for Nighttime (in each 10 mL)

    Acetaminophen 325 mg

    Diphenhydramine HCI 12.5 mg

    Phenylephrine HCI 5 mg

  • Active ingredients for Daytime (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Guaifenesin 100 mg

    Phenylephrine HCl 2.5 mg

  • Purpose for Nighttime

    Pain reliever / fever reducer

    Antihistamine / Cough suppressant

    Nasal Decongestant

  • Purpose for Daytime

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    Nighttime

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

    Daytime

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
    • temporarialy 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

    NIGHTTIME

    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

    Nighttime

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist 
    • in a child who is taking 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
    • with any other drug containing diphenhydramine, even one used on skin.
    • If your child is allergic to acetaminophen or any of the inactive ingredients in this product
    • to make a child sleepy

    Daytime

    • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. 

    Ask a doctor before use if you have

    Nighttime

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

    Daytime

    • 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

    Ask a doctor or pharmacist before use if you are

    Nighttime

    • taking the blood thinning drug warfain
    • taking sedative or tranquilizers

    When using these products

    Nighttime

    • do not use more than directed
    • marked drowsiness may occur
    • excitablity may occur, especially in children
    • sedatives and tranquilizer may increase drowsiness

    Daytime

    • do not use more than directed

    Stop use and ask a doctor if

    Nighttime

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

    Daytime

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

    Keep out of reach of children.

    Nighttime

    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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.

    Daytime

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Nighttime

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see Overdose warning)
    • do not give more than 5 doses in any 24-hour period
    • 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 any other dosing device.
    • mL = milliliter
    • dose as follows or as directed by a doctor
    • children 6 to under 12 years of age: 10 mL every 4 hours
    • children under 6 years of age: do not use

    Daytime

    • do not take more than 6 doses in any 24-hours period
    • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device
    • keep dosing cup with product
    • dose as follows, or as directed by a doctor
    • mL = milliliter
    Age Dose 
     children 6 years to under 12 years 10 mL every 4 hours
     children 4 years to under 6 years 5 mL every 4 hours
     children under 4 years do not use

  • Other information

    Nighttime

    • each 10 mL contains: sodium 5 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.

    Daytime

    • each 5 mL contains: 4 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    Nighttime

    citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

    Daytime

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

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold**

    Children's

    multi-symptom

    Nighttime Cold

    ACETAMINOPHEN 325 mg (pain reliever / fever reducer)

    DIPHENHYDRAMINE HCI 12.5 mg (Antihistamine-Cough Suppressant)

    PHENYLEPHRINE HCI 5 mg (Nasal Decongestant)

     Relieves:

    Nasal and chest congestion

    Reduces fever

    Soothes cough and sore throat

    Berry Flavor Liquid

    Dosage Cup Included

    Ages 6 - 11 Years

    FL OZ (mL)

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    **This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Multi-Symptom Time Cold

    DAYTIME

    Compare to active ingredients in Children's Mucinex® Multi-Symptom Cold*

    Children's

    multi-symptom cold

    DEXTROMETHORPHAN HBr 5 mg (Cough Suppressant)

    GUAIFENESIN 100 mg (expectorant)

    PHENYLEPHRINE HCI 2.5 mg (Nasal Decongestant)

    Relieves:

    Nasal and chest congestion

    Soothes cough

    Thins and loosens mucus

    Berry Flavor Liquid

    Dosage cup included

    Ages 4 to 11 years

    FL OZ (mL)

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    1-800-SHOP CVS

  • Product Label

    Acetaminophen 325 mg, Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg Dextromethorphan HBr 5 mg, Guaifenesin 100 mg, Phenylephrine HCI 2.5 mg

    CVS HEALTH Children's Multi-Symptom Nighttime Cold Children's Multi-Symptom Cold

  • INGREDIENTS AND APPEARANCE
    MULTI SYMPTOM COLD AND MULTI SYMPTOM NIGHTTIME COLD  CHILDRENS
    dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-820
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-820-081 in 1 KIT; Type 0: Not a Combination Product02/28/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    MULTI SYMPTOM COLD DAYTIME  CHILDRENS
    dextromethorphan hbr, guaifenesin, phenylephrine hci liquid
    Product Information
    Item Code (Source)NDC:69842-607
    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 CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    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)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-607-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/28/2017
    Part 2 of 2
    MULTI SYMPTOM NIGHTTIME COLD  CHILDRENS
    acetaminophen, diphenhydramine hci, phenylephrine hci liquid
    Product Information
    Item Code (Source)NDC:69842-606
    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 CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    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)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-606-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/28/2017
    Labeler - CVS Pharmacy (062312574)

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