FDA Label for Desgen Pediatric
View Indications, Usage & Precautions
Desgen Pediatric Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Novis. 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 - Active Ingredient
Active Ingredients (in each 1 mL) Purpose
Dextromethorphan HBr, 5 mg..............................Antitussive
Guaifenesin, 50 mg..............................................Expectorant
Phenylephrine HCl, 2.5 mg................................Nasal decongestant
Otc - Purpose
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- nasal congestion due to the common cold
- cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
Warnings
Do not use
in 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 a MAOI, ask a doctor or pharmacist before giving this product.
Otc - Do Not Use
Ask a doctor before use if your child has
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- a cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with asthma
- new symptoms occur
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
do not use more than 6 doses in any 24-hour period
Children 2 to under 5 years of age
- 1 mL every 4 hours, do not exceed 6 doses, or as directed by a doctor.
- measure with the dosage device provided. Do not use any other device.
Children under 2, consult a doctor.
Indications & Usage
Other information
Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.
Store at controlled room temperature 15-30°C (59-86°F).
Avoid excessive heat and humidity.
Inactive Ingredient
Inactive ingredients Citric acid, flavors, glycerin, methyl paraben, polyethylene glycol, propylene glycol, propyl paraben, purified water, sodium citrate, sorbitol and sucralose.
Otc - Questions
Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072
Principal Display Panel
DESGEN
PEDIATRIC DROPS
Contains the same active ingredients as Despec® EDA drops
Antitussive
Expectorant
Nasal Decongestant
Sugar, Alcohol & Dye Free
NET CONTENT: 30 mL (1 Fl. Oz.)
KRAMER-NOVIS
* Please review the disclaimer below.