Label: DR COCOA DAY NIGHT COMBO- dextromethorphan hydrobromide,diphenhydramine hydrochloride kit

  • 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 March 3, 2020

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

  •                                                                                                                                Nighttime Cough + ColdDrug Facts

  • Active ingredients

    Diphenhydramine HCl 6.25 mg

    Phenylephrine HCl 2.5 mg

  • Purpose

    Antihistamine/Cough suppressant

    Nasal decongestant

  • Uses

    Temporarily relieves:
    sneezing
    itchy nose or throat
    runny nose
    itchy, watery eyes
    cough due to minor throat and bronchial irritation as may occur with a cold
    nasal congestion
  • Warnings

    Do not use

    to make a child sleepy
    in a child under 6 years of age
    with any other drug containing diphenhydramine, even one used on the skin
    in a child now 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 using this product

    Ask a doctor before use if your child has

    heart disease
    diabetes
    high blood pressure
    thyroid disease
    glaucoma
    trouble urinating due to an enlarged prostate gland
    breathing problems 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 sedatives or tranquilizers

    When using this product

    do not use more than directed
    excitability in your child may occur
    marked drowsiness in your child may occur
    sedatives and tranquilizers may increase drowsiness

     Stop use and ask a doctor if

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

     Keep out of the reach of children. Dr. Cocoa™ is a medicine.

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

  • Directions

    shake well before use
    measure only with the provided double-ended dosing spoon
    read dosing spoon carefully and select the correct spoon:
    large dosing spoon holds 5 mL when filled to the top rim
    small spoon holds 2.5 mL when filled to the top rim
    do not use dosing spoon with other products
    dose as follows or as directed by a doctor
    mL=milliliter

    Age (year)

    Dose (mL)

    children 12 and 13 years of age

    20 mL every 4 hours; do not take more than 120 mL in 24 hours

    children 6 to under 12 years of age

    10 mL every 4 hours; do not take more than 60 mL in 24 hours

    children under 6 years of age

    do not use

  • Other information

    each 5 mL contains: sodium 7 mg
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    anhydrous citric acid, cocoa, maltitol, methylparaben, natural flavor, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

  • Questions or comments?

    Call 1-855-848-3284 toll free

  •                                                                                                                                Daytime Cough + ColdDrug Facts

  • Active ingredients

    Dextromethorphan HBr 5mg

    Phenylephrine HCl 2.5 mg

  • Purpose

    Cough suppressant

    Nasal decongestant

  • Uses

    Temporarily relieves:
    cough due to minor throat and bronchial irritation as may occur with a cold
    nasal congestion
  • Warnings

    Do not use in a child under 4 years of age, in a child now 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 using this product

    Ask a doctor before use if your child has

    heart disease
    diabetes
    high blood pressure
    thyroid disease
    trouble urinating due to an enlarged prostate gland
    persistent or chronic cough such as occurs with asthma
    cough that occurs with too much phlegm (mucus)
    sodium restricted diet

    When using this product do not use more than directed.

    Stop use and ask a doctor if

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

    Keep out of the reach of children. Dr. Cocoa™ is a medicine.

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

  • Directions

    shake well before use
    measure only with the provided double-ended dosing spoon
    read dosing spoon carefully and select the correct spoon:
    large dosing spoon holds 5 mL when filled to the top rim
    small spoon holds 2.5 mL when filled to the top rim
    do not use dosing spoon with other products
    dose as follows or as directed by a doctor
    mL=milliliter

    Age (year)

    Dose (mL)

    children 12 and 13 years of age

    20 mL every 4 hours; do not take more than 120 mL in 24 hours

    children 6 to under 12 years of age

    10 mL every 4 hours; do not take more than 60 mL in 24 hours

    children 4 to under 6 years of age

    consult your doctor before use

    5 mL every 4 hours; do not take more than 30 mL in 24 hours

    children under 4 years of age

    do not use

  • Other information

    each 5 mL contains: sodium 7 mg
    store at 20-25°C (68-77°)
  • Inactive ingredients

    anhydrous citric acid, cocoa, maltitol, methylparaben, natural flavor, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

  • Questions or comments?

    Call 1-855-848-3284 toll free

  • PRINCIPAL DISPLAY PANEL - 240 mL Carton

    Dr.
    Cocoa™

    ....................
    for Children

    Day + Night
    Combo Pack

    Daytime
    Cough+Cold

    Dextromethorphan HBr (Cough Suppressant)
    Phenylephrine HCl (Nasal Decongestant)

    Relieves:

    Cough
    Stuffy Nose

    For Ages 4-13

     

    Nighttime
    Cough+Cold

    Diphenhydramine HCl (Antihistamine/Cough Suppressant)
    Phenylephrine HCl (Nasal Decongestant)

    Relieves:

    Cough
    Stuffy Nose
    Runny Nose
    Sneezing

    Helps Your Child Rest

    For Ages 6-13

     

    Real Chocolate Taste

    4 FL OZ (120 mL)      8 FL OZ (240 mL) TOTAL       4 FL OZ (120 mL)

    Dr. Cocoa Day + Night carton label image
  • INGREDIENTS AND APPEARANCE
    DR COCOA  DAY NIGHT COMBO
    dextromethorphan hydrobromide,diphenhydramine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-732
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-732-041 in 1 CARTON; Type 0: Not a Combination Product06/20/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 120 mL
    Part 21 BOTTLE 120 mL
    Part 1 of 2
    DR. COCOA DAYTIME COUGH AND COLD 
    dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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)  
    COCOA (UNII: D9108TZ9KG)  
    MALTITOL (UNII: D65DG142WK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/20/2014
    Part 2 of 2
    DR. COCOA NIGHTTIME COUGH AND COLD 
    diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 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)  
    COCOA (UNII: D9108TZ9KG)  
    MALTITOL (UNII: D65DG142WK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/20/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/20/2014
    Labeler - Infirst Healthcare (079159739)