Label: PECGEN DMX- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 52083-630-16
- Packager: KRAMER NOVIS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 16, 2019
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 5 mL tsp)
- Purposes
- Uses
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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
• cough that occurs with too much phlegm (mucus)
• a 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
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Inactive ingredients
- Other information
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SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Trispec® DMX*
Sugar, Alcohol, Dye and Gluten FREE
CHERRY RASPBERRY FLAVOR
Manufactured in the USA for Kramer Novis
*Trispec® DMX is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.
- Packaging
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INGREDIENTS AND APPEARANCE
PECGEN DMX
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-630 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 187 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) 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 CHERRY, RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-630-16 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2015 Labeler - KRAMER NOVIS (090158395)
