FDA Label for Sanatos Childrens Mucus Relief Cough
View Indications, Usage & Precautions
Sanatos Childrens Mucus Relief Cough Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel 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.
Otc - Purpose
| Active Ingredients
(in each 5 mL teaspoonful) | Purpose |
|---|---|
| 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 the bronchial tubes
Warnings
Do not use in 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 Id The Child Has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back or occurs with fever, rash, or persistent headache.
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
| Age | Dose |
|---|---|
| Children 6 years to under 12 years | 1-2 teaspoonful s (tsps) every 4 hours |
| Children 4 years to under 6 years | ½-1 teaspoonful (tsp) every 4 hours |
| Children under 4 years | do not use |
Other Information
- each teaspoon contains: sodium 3 mg
- store between 20-25 C (68-77 F)
- do not refrigerate
- dosage cup provided
- Keep cartoon for full directions for use
Inactive Ingredients
Anhydrous citric acid, dextrose, D&C Red #33, FD&C Red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944
Other
Distributed by
PHARMDEL®
Seaford, DE 19973
Principal Display Panel - 118 Ml Bottle Carton
NDC # 55758-007-04
SanaTos®
Children's
Mucus Relief
COUGH
Cherry Flavor
Dextromethorphan HBr
Cough Suppressant
Guafenesin
Expectorant
Relieves Chest Congestion
Thins & Loosens Mucus
Alcohol-Free
For Ages 4 to 12
4 FL OZ (118 mL)
* Please review the disclaimer below.