Label: SORBUGEN- dextromethorphan hydrobromide, glycerol guaiacolate syrup
- NDC Code(s): 52083-660-16
- 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 October 15, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients (in each 7.5 mL 1½ 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) • 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
• 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
- Other information
- Inactive Ingredients
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SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Sorbutuss® NR*
Dextromethorphan HBr
ANTITUSSIVE
Glyceryl Guaiacolate (Guaifenesin)
EXPECTORANT
Antihistamine & Decongestant Free
SUGAR DYE & ALCOHOL FREE
GRAPE FLAVOR
Manufactured in the USA for Kramer Novis. San Juan, PR 00917
Tel: (787) 767-2072 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) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) 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 final part341 10/08/2014 Labeler - Kramer Novis (090158395) Registrant - Kramer Novis (090158395)