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Desgen

Kramer Novis

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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



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

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.


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

When using this product do not exceed recommended dosage

Stop use and ask a doctor if
  • 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.

If pregnant or breast-feeding, ask a health professional before use.



Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.



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.

Children under 2, consult a doctor.

  • measure with the dosage device provided. Do not use any other device.

Uses


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 ingredients
Citric acid, flavors, glycerin, methyl paraben, polyethylene glycol, propylene glycol, propyl paraben, purified water, sodium citrate, sorbitol and sucralose.

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

Desgen

Desgen

Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52083-641
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Guaifenesin GUAIFENESIN 50 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
METHYLPARABEN
POLYETHYLENE GLYCOLS
propylene glycol
PROPYLPARABEN
water
SODIUM CITRATE
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52083-641-01 30 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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