Otc - Purpose
| Active Ingredients (in each 5 mL teaspoonful) | Purposes |
|---|---|
| Dextromethorphan HBr 5 mg | Cough Suppressant |
| Guaifenesin 100 mg | Expectorant |
Sanatos Children Cough And Congestion Cherry Liquid
FDA Label NDC 55758-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos Children Cough And Congestion Cherry (NDC 55758-013). 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, uses, warnings, do not use, ask a doctor before use, if the child has a, 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.
Label Section Quick Index
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common 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.
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 A
- cough that is accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Stop Use And Ask A Doctor, If The Child Has A
- cough lasts more than 7 days, tends to come back, or accompained 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 Poison Control Center right away.
Directions
do not give a child more than 6 doses in any 24-hour period
| Age | Dose |
|---|---|
| Children 6 to under 12 years of age | 1-2 teaspoonful s (tsps) every 4 hours |
| Children 2 to under 6 years of age | ½-1 teaspoonful (tsp) every 4 hours |
| Children under 2 years of age | consult a doctor |
Other Information
- sodium: 3 mg per teasponful
- store at 20- 25° C (68- 77° F)
- do not refrigerate
- dosage cup included
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.
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?
1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Distributed By:
PHARMDEL®
Seaford, DE 19973
Principal Display Panel
SanaTos®
Children
Cough & Chest Congestion
Cherry Flavor
COUGH SUPPRESANT• EXPECTORANT
Dextromethorphan HBr • Guafenesin
Helps Loosen Chest Congestion
- ALCOHOL FREE
- NON-DROWSY
For Ages 2 to 12
4 FL OZ (118 mL)
* Please review the disclaimer below.
