DR. COCOA NIGHTTIME COUGH AND COLD- diphenhydramine hydrchloride, phenylephrine 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 Nighttime Cough+Cold
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
- •
- 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 chronic bronchitis
- •
- persistent or chronic cough such as occurs with asthma
- •
- cough that occurs with too much phlegm (mucus)
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
Directions
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- 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 |
Inactive ingredients
anhydrous citric acid, cocoa, maltitol, methylparaben, natural flavor, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label
Dr.
Cocoa™
....................
for Children
Nighttime
Cough+Cold
Diphenhydramine HCl
(Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
For Ages
6-13
4 FL OZ (120 mL)
PRINCIPAL DISPLAY PANEL - 120 mL Carton
NDC 62372-743-04
NEW!
Dr.
Cocoa™
....................
for Children
Nighttime
Cough+Cold
Diphenhydramine HCl
(Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Relieves:
Cough
Stuffy Nose
Runny Nose
Sneezing
Helps Your
Child Rest
For Ages 6-13
Real Chocolate Taste
4 FL OZ (120 mL)
| DR. COCOA NIGHTTIME COUGH AND COLD
diphenhydramine hydrchloride, phenylephrine hydrochloride liquid |
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| Labeler - Infirst Healthcare (079159739) |
| Registrant - Woodfield Pharmaceutical, LLC (079398730) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Woodfield Pharmaceutical, LLC | 079398730 | MANUFACTURE(62372-743) | |