DR. COCOA DAYTIME COUGH AND COLD- dextromethorphan hydrobromide 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 Daytime Cough+Cold

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

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.

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 Daytime 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 65224-721-04

Dr.

Cocoa™

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

for Children

Daytime

Cough+Cold

Dextromethorphan HBr (Cough Suppressant)

Phenylepherine HCl (Nasal Decongestant)

For Ages 4+

120 mL (4 FL OZ)

Dr. Cocoa Daytime Cough+Cold Bottle Label

PRINCIPAL DISPLAY PANEL - 120 mL Carton


NDC 65224-721-04

NEW!

Dr.

Cocoa™

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

for Children

Daytime

Cough+Cold

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves:

Cough

Stuffy Nose

For Ages 4+

Real Chocolate Taste

120 mL (4 FL OZ)

Dr. Cocoa Daytime Cough+Cold

DR. COCOA DAYTIME COUGH AND COLD 
dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65224-721
Route of AdministrationORALDEA Schedule    
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
1NDC:65224-721-041 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 finalpart34102/01/201405/31/2015
Labeler - Pernix Therapeutics, LLC (004672296)

Revised: 6/2015
Document Id: 76d4a0fa-ba93-4774-8244-127315016e37
Set id: 1b1acf71-12cb-44e3-823e-8c18cc3d5712
Version: 3
Effective Time: 20150605
 
Pernix Therapeutics, LLC