DR COCOA DAY NIGHT COMBO- dextromethorphan hydrobromide,diphenhydramine hydrochloride 
Infirst Healthcare

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.

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Dr. Cocoa Day Night Combo Pack

                                                                                                                               Nighttime Cough + Cold
Drug 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 + Cold
Drug 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)

Dr. Cocoa Day + Night carton label image
DR COCOA  DAY NIGHT COMBO
dextromethorphan hydrobromide,diphenhydramine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-732
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62372-732-041 in 1 CARTON; Type 0: Not a Combination Product06/20/201405/31/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 120 mL
Part 21 BOTTLE 120 mL
Part 1 of 2
DR. COCOA DAYTIME COUGH AND COLD 
dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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
11 in 1 CARTON
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 finalpart34106/20/201405/31/2021
Part 2 of 2
DR. COCOA NIGHTTIME COUGH AND COLD 
diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
Product Information
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
11 in 1 CARTON
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 finalpart34106/20/201405/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/20/201405/31/2021
Labeler - Infirst Healthcare (079159739)

Revised: 7/2022
 
Infirst Healthcare