FDA Label for Drkids Childrens Cough And Chest Congestion Dm
View Indications, Usage & Precautions
Drkids Childrens Cough And Chest Congestion Dm Product Label
The following document was submitted to the FDA by the labeler of this product Calmco Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5Ml)
Dextromethorphan HBr, USP, 5mg
Guaifenesin, USP, 100mg
Purpose
Cough suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Do Not Use
if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two 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
persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).
Stop Use And Ask A Doctor If
cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
do not give more than 6 doses in any 24 hour period
give the recommended number of vials below, following the instructions under How to Open and Use on the side panel
empty all liquid in each Single-Use Vial when dosing
Dosing Chart
| Age (Years) | Dose |
| under 4 years | Consult a doctor |
| 4 – 5 years | 1 Single-Use Vial (5 mL) every 4 hours |
| 6 – 11 years | 1 – 2 Single-Use Vials (5 mL each) every 4 hours |
| Adults and children 12 years and over | 2 – 4 Single-Use Vials (5 mL each) every 4 hours |
Inactive Ingredients
citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum
Other Information
- each Single-Use vial contains 6mg of sodium
- store at 20-25°C (68-77°F)
- tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
Questions Or Comments?
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