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

Dr. Cocoa Nighttime Cough and Cold by

Drug Labeling and Warnings

Dr. Cocoa Nighttime Cough and Cold by is a Otc medication manufactured, distributed, or labeled by Infirst Healthcare, Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-743
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-743-04	1 in 1 CARTON	12/20/2014
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/20/2014

Labeler - Infirst Healthcare (079159739)

Registrant - Woodfield Pharmaceutical, LLC (079398730)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(62372-743)