FDA Label for Pediacare Childrens Cough And Congestion Grape
View Indications, Usage & Precautions
Pediacare Childrens Cough And Congestion Grape Product Label
The following document was submitted to the FDA by the labeler of this product Randob Labs,ltd. Dba Crossingwell Consumer Health. 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.
Other
Drug Facts
Distributed by
CrossingWell Consumer Health
PO Box 440
Cornwall, NY 12518
Otc - Purpose
| Active ingredients (in each 5 mL) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough suppressant |
| Guaifenesin, USP 100 mg | 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 drain bronchial tubes
Otc - Do Not Use
Do not use if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - Stop Use
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- mL=milliliter
| AGE | DOSE |
|---|---|
| children under 4 years | do not use |
| children 4 to under 6 years | 5 mL every 4 hours |
| children 6 to under 12 years | 10 mL every 4 hours |
| adults and children 12 years and over | 20 mL every 4 hours |
Other Information
- store at 20-25°C (68-77°F)
- do not refrigerate
- alcohol-free
Inactive Ingredients
acesulfame potassium, citric acid anhydrous, glycerin, flavor, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin
Principal Display Panel - 118 Ml Bottle Carton
Fast Acting
Pedia
Care®
100% dedicated
to kids™
4 Years & Up
COUGH &
CONGESTION
Relieves:
- Congestion & Mucus
- Cough
Dextromethorphan HBr, USP (5 mg per 5 mL)
Guaifenesin, USP (100 mg per 5 mL)
Non-Drowsy
Grape Flavor
4 FL OZ (118 mL)
* Please review the disclaimer below.
