Label: SORBUGEN- dextromethorphan hydrobromide, glycerol guaiacolate syrup
- NDC Code(s): 52083-660-16
- Packager: Kramer Novis
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients (in each 7.5 mL, 1 ½ teaspoon)
- 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)
• 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
• 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
- Other information
- Inactive Ingredients
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SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Sorbutuss® NR*
Dextromethorphan HBr
ANTITUSSIVE
Guaifenesin (Glyceryl Guaiacolate)
EXPECTORANTAntihistamine & Decongestant Free
SUGAR, DYE & ALCOHOL FREE
GRAPE FLAVOR
KramerNovis
Pharmaceuticals within reach of patientsManufactured in USA with imported ingredients for Kramer Novis,
San Juan, PR 00917.
www.kramernovis.com
*Sorbutuss® NR is a registered trademark of Teral, Inc.
This product is not manufactured, distributed or marketed by Teral, Inc. - Packaging
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INGREDIENTS AND APPEARANCE
SORBUGEN
dextromethorphan hydrobromide, glycerol guaiacolate syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-660 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 7.5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 150 mg in 7.5 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) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE (SWEET GRAPE) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-660-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/08/2014 Labeler - Kramer Novis (090158395) Registrant - Kramer Novis (090158395)

