Dr. Cocoa Day Night Combo Pack

Dr. Cocoa Day Night Combo Pack

Drug Labeling and Warnings

Drug Details

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

Drug Facts

Active ingredient

(in each 5 mL)

Dextromethorphan HBr 7.5 mg

Purpose

Cough suppressant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold

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

  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if 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 reach of children. Dr. Cocoa TM is a medicine. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Directions

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

Dr.

Cocoa™

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

for Children

Non-Drowsy

Cough

Dextromethorphan HBr (Cough Suppressant)

For Ages

4-13

4 FL OZ (120 mL)

Product Label

PRINCIPAL DISPLAY PANEL - 120 mL Carton

NDC: 62372-700-04

NEW!

Dr.

Cocoa™

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

for Children

Non-Drowsy

Cough

Dextromethorphan HBr, 7.5 mg

(Cough Suppressant)

Relieves:

Cough up to

8 hours

For Ages 4-13

Real Chocolate Taste

4 FL OZ (120 mL)

Product Carton

DR COCOA  DAY NIGHT COMBO
dextromethorphan hydrobromide,diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62372-732
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
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 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: 62372-732-041 in 1 CARTON06/20/2014
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 finalpart34106/20/2014
Labeler - Infirst Healthcare (079159739)
Registrant - Woodfield Pharmaceutical, LLC (079398730)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(62372-732)

Revised: 12/2019
 
Infirst Healthcare


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