DR. COCOA MUCUS RELIEF- guaifenesin, phenylephrine hydrochloride liquid 
Infirst Healthcare, Inc.

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.

----------

Dr. Cocoa Mucus Relief

Drug Facts

Active ingredients

(in each 5 mL)

Guaifenesin 50 mg

Phenylephrine HCl 2.5 mg

Purpose

Expectorant

Nasal decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • nasal congestion due to a cold
  • stuffy nose

Warnings

Do not use: 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 giving this product.

Ask a doctor before use if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with asthma, chronic bronchitis, smoking, or emphysema
  • cough accompanied by excessive 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 are accompanied by fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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 10 mL when filled to the top rim
  • small spoon holds 5 mL when filled to the rop 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

childen 4 to under

6 years of age

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 3 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, cocoa, maltitol, methylparaben, natural flavor, propylene glycol, purified water, saccharin sodium, 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

Mucus Relief

Guaifenesin (Expectorant)

Phenylephrine HCl (Nasal Decongestant)

For Ages

4-13

4 FL OZ (120 mL)

Dr. Cocoa Mucus Relief

Principal Display Panel - 120 mL Carton

NDC 62372-710-04

NEW!

Dr.

Cocoa ®

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

for Children

Mucus Relief

Guaifenesin (Expectorant)

Phenylephrine HCl (Nasal Decongestant)

Relieves:

Chest Congestion

Mucus Build-Up

Stuffy Nose

Contains the

#1

Selling Ingredient for

Mucus Relief

For Ages

4-13

Real Chocolate Taste

4 FL OZ (120 mL)

Dr. Cocoa Mucus Relief Carton

DR. COCOA MUCUS RELIEF 
guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-710
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
COCOA (UNII: D9108TZ9KG)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MALTITOL (UNII: D65DG142WK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62372-710-041 in 1 CARTON07/22/2015
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 finalpart34107/22/201512/31/2017
Labeler - Infirst Healthcare, Inc. (079159739)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(62372-710)

Revised: 12/2017
 
Infirst Healthcare, Inc.