Label: DESGEN DM TABS- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet
- NDC Code(s): 52083-648-10
- Packager: KRAMER NOVIS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 4, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each tablet)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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.
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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
- STORAGE AND HANDLING
-
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 tabletProduct 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) MICROCRYSTALLINE CELLULOSE (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 Drug M012 08/26/2015 Labeler - KRAMER NOVIS (090158395) Registrant - KRAMER NOVIS (090158395)
