DR. COCOA NIGHTTIME COUGH AND COLD- diphenhydramine hydrochloride and phenylephrine hydrochloride liquid 
Pernix Therapeutics, LLC

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 Nighttime Cough+Cold

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
  • with any other drug containing diphenhydramine, even one used on the skin
  • if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • breathing problems such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before use
  • measure only with dosing spoon provided
  • read dosing spoon carefully.  Dosing spoon holds 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
Dr. Cocoa Nighttime Cough+Cold Dosing Chart


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


NDC 65224-743-04

Dr.

Cocoa™

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

for Children

Nighttime

Cough+Cold

Diphenhydramine HCl

(Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

For Ages 6+

120 mL (4 FL OZ)

Dr. Cocoa Nighttime Cough+Cold Label

PRINCIPAL DISPLAY PANEL - 120 mL Carton


NDC 65224-743-04

NEW!

Dr.

Cocoa™

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

for Children

Nighttime

Cough+Cold

Diphenhydramine HCl

(Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves:

Cough

Stuffy Nose

Runny Nose

Sneezing

For Ages 6+

Real Chocolate Taste

120 mL (4 FL OZ)

Dr. Cocoa Nighttime Cough+Cold Carton

DR. COCOA NIGHTTIME COUGH AND COLD 
diphenhydramine hydrchloride, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65224-743
Route of AdministrationORALDEA Schedule    
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
1NDC:65224-743-041 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/201405/31/2015
Labeler - Pernix Therapeutics, LLC (004672296)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(65224-743)

Revised: 3/2015
 
Pernix Therapeutics, LLC