FDA Label for Pediacare Childrens Cough And Congestion
View Indications, Usage & Precautions
Pediacare Childrens Cough And Congestion Product Label
The following document was submitted to the FDA by the labeler of this product Strides Pharma Inc. 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 Ingredients
(in each 5 mL)
Dextromehorphan HBr, 5 mg
Guaifenesin, 100 mg
Purpose
Dextromehorphan HBr, 5 mg…….Cough suppressant
Guaifenesin, 100 mg…….………..Expectorant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
Warnings
Do not use for a child who is 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 the child has
- cough that occurs with excessive phlegm (mucus)
- persistent or chronic cough such as occurs with asthma or chronic bronchitis
Stop Use And Ask A Doctor If
- cough gets worse or last more than 7 days
- cough comes back or occurs with fever, rash, or persistent headache.
These could be signs of a serious illness.
When using this product do not use more than directed
Keep Out Of Reach Of Children
In case of overdose, seek medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- this product does not contain directions or complete warnings for adult use
- use only the dosing cup provided
- do not exceed 6 doses in a 24-hour period
- mL = milliliter
| Age (yrs) | Dose (ml) |
| under 4 years | do not use |
| 4 to under 6 yrs | 2.5-5 mL every 4 hours |
| 6 to 11 yrs | 5-10 mL every 4 hours |
Other Information
- each 5 mL contains:sodium 3 mg
- store at room temperature
- dosage cup provided
Inactive Ingredients
acesulfame potassium, citric acid, FD&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium chloride, sodium citrate, sucralose, sucrose
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PediaCare® Children Cough & Congestion
Non Drowsy
4 FL OZ FL (118 mL)
Cherry Flavor
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