FDA Label for Sanatos Mucus Relief Cold Toddlers
View Indications, Usage & Precautions
Sanatos Mucus Relief Cold Toddlers 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 2.5 mL) | Purposes |
Dextromethorphan HBr, 2.5 mg ..... | Cough suppressant |
Guaifenesin, 50 mg............ | Expectorant |
Use
- 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
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 If The Child Has
- cough that is accompanied by excessive phlegm (mucus) or
- 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 The Child Has A
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not give a child more than 6 doses in any 24-hour period
- repeat the dose every 4 hours
- measure with the dosing device provided
- do not use any other dosing device
Age Dose Children 2 to under 6 years of age 2.5 mL every 4 hours Children under 2 years of age ask a doctor
Other Information
- each dose (2.5 mL) contains: sodium 1.5 mg
- store between 20-25°C (68-77°F)
- oral dosing device included
- do not refrigerate
- Keep carton for full direction for use
Inactive Ingredients
anhydrous citric acid, D&C red #33, dextrose monohydrate, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum
Questions Or Comments?
1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Principal Display Panel
Sanatos
Toddlers
Mucus Relief
Cough
Dextromethorphan HBr........Cough Suppressant
Guaifenesin...............................................Expectorant
FOR CHILDREN 2 TO UNDER 6 YEARS
Cherry Flavor
2 FL OZ (59 mL)
- ALCOHOL FREE
- NON-DROWSY
Includes Syringe
* Please review the disclaimer below.