Label: DR. COCOA NIGHTTIME COUGH AND COLD- diphenhydramine hydrchloride, phenylephrine hydrochloride liquid

  • 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 November 2, 2021

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

  • Drug Facts

    Active ingredients

    (in each 5 mL)

    Diphenhydramine HCl 6.25 mg

    Phenylephrine HCl 2.5 mg

    Purpose

    Antihistamine/Cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves:
    • sneezing
    • runny nose
    • itchy nose or throat
    • 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 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 reach of children.Dr. Cocoa TM is a medicine. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    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

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

    Dr.

    Cocoa™

    ....................

    for Children

    Nighttime

    Cough+Cold

    Diphenhydramine HCl

    (Antihistamine/Cough Suppressant)

    Phenylephrine HCl (Nasal Decongestant)

    For Ages

    6-13

    4 FL OZ (120 mL)

    Product Label

  • PRINCIPAL DISPLAY PANEL - 120 mL Carton



    NDC 62372-743-04

    NEW!

    Dr.

    Cocoa™

    ....................

    for Children

    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)

    Product Carton

  • INGREDIENTS AND APPEARANCE
    DR. COCOA NIGHTTIME COUGH AND COLD 
    diphenhydramine hydrchloride, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-743
    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
    1NDC:62372-743-041 in 1 CARTON12/20/2014
    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
    Labeler - Infirst Healthcare (079159739)
    Registrant - Woodfield Pharmaceutical, LLC (079398730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodfield Pharmaceutical, LLC079398730manufacture(62372-743)