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

Dr Cocoa by

Drug Labeling and Warnings

Dr Cocoa by is a Otc medication manufactured, distributed, or labeled by Infirst Healthcare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

                                                                                                                               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)

INGREDIENTS AND APPEARANCE

DR COCOA  DAY NIGHT COMBO
dextromethorphan hydrobromide,diphenhydramine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-732

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-732-04	1 in 1 CARTON; Type 0: Not a Combination Product	06/20/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	120 mL
Part 2	1 BOTTLE	120 mL

Part 1 of 2

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

Product Information
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		1 in 1 CARTON
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

Part 2 of 2

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

Product Information
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		1 in 1 CARTON
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

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)