DESGEN DM TABS- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet

DESGEN DM Tabs by

Drug Labeling and Warnings

DESGEN DM Tabs by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

 Active ingredients (in each tablet)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Pseudoephedrine HCl, 30 mg

Purpose

Antitussive

Expectorant

Nasal Decongestant

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants helps loosen phlegm and thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion

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  heart disease  high blood pressure  thyroid disease  diabetes  difficulty in urination due to enlarged prostate gland  persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema  cough accompanied by excessive phlegm (mucus)

When using this product  do not exceed recommended dosage

Stop use and ask a doctor if  cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition symptoms do not improve within 7 days or are accompanied by fever  nervousness, dizziness, or sleeplessness occur

If pregnant or breastfeeding ask a health professional before use.

Directions

Do not exceed recommended dosage.

• Adults and children 12 years of age and over:

  2 tablets every 4 hours,

  not to exceed 8 tablets

  in 24 hours or as

  directed by a doctor

• Children 6 to under 12 years of age:

  1 tablets every 4 hours,

  not to exceed 4 tablets

  in 24 hours or as

  directed by a doctor

• Children 2 under 6 years of age:

  ½ tablets every 4 hours,

  not to exceed 2 tablets

  in 24 hours or as

  directed by a doctor

• Children under 2 years of age: Consult physician

INACTIVE INGREDIENT

Inactive ingredients: Magnesium Stearate, microcrystalline cellulose, sodium starch glycolate

STORAGE AND HANDLING

Other information

• Store at room temperature 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing

SPL UNCLASSIFIED SECTION

New Formulation

Contains the same active ingredients as Despec® DM Tablets*

ANTITUSSIVE EXPECTORANT NASAL DECONGESTANT

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

* Despec® DM Tablets is a registered trademark of International Ethical Laboratories. This product is not manufactured, distributed or marketed by International Ethical Laboratories.

Packaging

INGREDIENTS AND APPEARANCE

DESGEN DM TABS 
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-648
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	KN648
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-648-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/26/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/26/2015

Labeler - KRAMER NOVIS (090158395)