Dr Cocoa

Manufacturer
Infirst Healthcare
Effective date
2020-03-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:39:26

Label at a glance#

ProductDr Cocoa Day Night Combo
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Indications and 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

Dosage and administration

• 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 2...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine/Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-848-3284 toll free

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5mg

Phenylephrine HCl 2.5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-848-3284 toll free

PRINCIPAL DISPLAY PANEL - 240 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Dr. Cocoa Day + Night carton label image

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62372-73262372-732-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
419156ad-021f-43c4-9173-03db4d04d88898e8e0d7-1bff-6aa8-e053-2995a90a060d2022-07-20WarningsExact identifier
spl set id: 98e8e0d7-1bff-6aa8-e053-2995a90a060d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.