Active Ingredients (In Each 15Ml Tsp)
Guaifenesin 100 mg………………………………Expectorant
Dextromethorphan HBr 10 mg……………………Cough suppressant
Defensolito Children Syrup
FDA Label NDC 53145-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Defensolito Children Syrup (NDC 53145-008). 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 active ingredients (in each 15ml tsp), purpose, uses, warnings do not exceed recommended dosage., do not use:, keep this and all drugs out of the reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Cough Suppressant
Uses
Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.
Warnings Do Not Exceed Recommended Dosage.
A persistent cough may be a sign of a serious condition. If cough oersistent for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
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 a pharmacist giving this product.
- this product for persistent or chronic cough such as occur with asthma, or if cough is accompanied ny excessive phlegm (mucus) unless directed by a doctor.
Keep This And All Drugs Out Of The Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
do not exceed 6 doses in 24 hours
| Age | Dose |
| Children 6 to under 12 years of age | 1 tablespoonful (15mL) every 4 hours |
| Children 2 to under 6 years of age | 1/2 tablespoonful (7.5 mL) every 4 hours |
| Children under 2 years of age | consult your doctor |
Other Information
store this product between 15° to 30° C (59° to 86°F)
Inactive Ingredients
citric acid, D&C red #33, glycerin, methylparaben, natural raspberry flavor, propylene glycol, propylparaben, sucrose and water.
Question?
call 1-800-560-5223 M-F 9 AM to 4 PM Eastern
* Please review the disclaimer below.
