FDA Label for Defensolito Children Syrup
View Indications, Usage & Precautions
Defensolito Children Syrup Product Label
The following document was submitted to the FDA by the labeler of this product Menper Distributors, Inc.. 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.
Active Ingredients (In Each 15Ml Tsp)
Guaifenesin 100 mg………………………………Expectorant
Dextromethorphan HBr 10 mg……………………Cough suppressant
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
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