Otc - Purpose
Active ingredients (in each 2.5 mL) | Purposes |
| Dextromethorphan HBr, 2.5 mg ..... | Cough suppressant |
| Guaifenesin, 50 mg............ | Expectorant |
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos Mucus Relief Cold Toddlers (NDC 55758-307). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, use, do not use, ask a doctor before use if the child has, when using this product, stop use and ask a doctor, if the child has a, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each 2.5 mL) | Purposes |
| Dextromethorphan HBr, 2.5 mg ..... | Cough suppressant |
| Guaifenesin, 50 mg............ | Expectorant |
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.
do not use more than directed
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
| 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 |
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
1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
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)
Includes Syringe
* Please review the disclaimer below.