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NDC 52083-0660-16 Sorbugen 15; 150 mg/7.5mL; mg/7.5mL Details

Sorbugen 15; 150 mg/7.5mL; mg/7.5mL

Sorbugen is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 52083-0660-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 52083-0660-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	52083-0660
Product ID	52083-660_13682546-cf2e-493d-a0fa-12777b7849fa
Associated GPIs	43997002520910
GCN Sequence Number	000652
GCN Sequence Number Description	guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	53491
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Sorbugen
Proprietary Name Suffix	n/a
Non-Proprietary Name	dextromethorphan hydrobromide, glycerol guaiacolate
Product Type	HUMAN OTC DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	15; 150
Active Ingredient Units	mg/7.5mL; mg/7.5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Kramer Novis
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52083-0660-16 (52083066016)

Pricing Information	N/A
NDC Package Code	52083-660-16
Billing NDC	52083066016
Package	480 mL in 1 BOTTLE (52083-660-16)
Marketing Start Date	2014-10-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8f2a2d7-0360-45a8-9635-c852f4a7d7ba Details

Drug Facts

Active Ingredients (in each 7.5 mL 1½ tsp)

Dextromethorphan HBr, 15 mg

Glyceryl Guaiacolate (Guaifenesin), 150 mg

Purposes

Antitussive

Expectorant

Uses

for the temporary relief of cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive

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.

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

Directions

do not take more than 6 doses in any 24-hour period


4 HOURS EVERY	Adults and Children 12 years of age and over	10 mL (2 tsp)
	Children 6 to under 12 years of age	5 mL (1 tsp)
	Children 2 to under 6 years of age	2.5 mL (½ tsp)
	Children under 2 years of age	Consult physician

Other information

Tamper evident feature: Do not use if inner seal is torn, broken or missing.
Store at controlled room temperature 15-30°C (59-86°F).
Avoid excessive heat or humidity.

Inactive Ingredients

Citric acid, glycerin, grape flavor, methyl paraben, potassium citrate, potassium sorbate, propyl paraben, purified water, sucralose

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

INGREDIENTS AND APPEARANCE

SORBUGEN

dextromethorphan hydrobromide, glycerol guaiacolate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52083-660
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52083-660-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/08/2014

Labeler - Kramer Novis (090158395)

Registrant - Kramer Novis (090158395)

Revised: 10/2022

Document Id: 13682546-cf2e-493d-a0fa-12777b7849fa

Set id: a8f2a2d7-0360-45a8-9635-c852f4a7d7ba

Version: 6

Effective Time: 20221015