DR. COCOA DAYTIME COUGH AND COLD- dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Dr. Cocoa Daytime Cough and Cold by

Drug Labeling and Warnings

Dr. Cocoa Daytime 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 ingredient

(in each 5 mL)

Dextromethorphan HBr 5 mg

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 reach of children. Dr. Cocoa TM is a medicine. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-122-1222).

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
• 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°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

Daytime

Cough+Cold

Dextromethorphan HBr (Cough Suppressant)

Phenylepherine HCl (Nasal Decongestant)

For Ages

4-13

4 FL OZ (120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Carton

NDC: 62372-721-04

NEW!

Dr.

Cocoa™

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

for Children

Daytime

Cough+Cold

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves:

Cough

Stuffy Nose

For Ages 4-13

Real Chocolate Taste

4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

DR. COCOA DAYTIME COUGH AND COLD 
dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-721
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 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: 62372-721-04	1 in 1 CARTON	06/20/2014
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(62372-721)