DESGEN DM- dextromethorphan hbr ,guaifenesin ,phenylephrine hcl solution

DESGEN DM by

Drug Labeling and Warnings

DESGEN DM by is a Otc medication manufactured, distributed, or labeled by Kramer Novis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL tsp)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Phenylephrine HCL, 5mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

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.

Uses

Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make   coughs more productive
temporarily relieves nasal congestion due to a cold

Warnings

Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not use more than directed

Stop use and ask a doctor if
you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.

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

Directions

Do not take more than 6 doses in any 24-hour period

Every 4 hours
Adult and Children 12 years of age and over           10 mL (2 tsp)
Children 6 to under 12 years of age                         5 mL (1 tsp)
Children under 6 years of age                                Consult physician

Inactive ingredients

Citric Acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

Other Information

Tamper evident feature: Do not use if inner seal is torn, broken or missing.
Store at controlled room temperature 15-30°C (59-86°F).
Avoid excessive heat or humidity

SPL UNCLASSIFIED SECTION

Manufactured in the USA for Kramer Novis, San Juan, PR 00917, Tel (787) 767-2072 / www.kramernovis.com

Packaging

INGREDIENTS AND APPEARANCE

DESGEN DM 
dextromethorphan hbr ,guaifenesin ,phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-646
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-646-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/18/2014

Labeler - Kramer Novis (090158395)

Registrant - Kramer Novis (090158395)