Label: SORBUTUSS NR- sorbutuss liquid
- NDC Code(s): 68436-120-16
- Packager: Dextrum Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 10, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval
OTC MonographINDICATIONS AND USAGE
- 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 makes cough more productive.
DOSAGE AND ADMINISTRATION
Follow dosage below or use as directed by a doctor. Do not exceed 6 doses in a 24 hours period. (8)
(8)
Adults and children 12 years and older 2 teaspoonfuls every 4 hours (8)
(8)
Children 6 years to under 6 years 1 teaspoonful every 4 hours (8)
(8)
Children 2 years to 6 years 1/2 teaspoonful every 4 hours (8)
(8)
Children under 2 years Consult a doctor (8)
Revised: 1/2007
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Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
Active Ingredients
Purpose Section
These highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval
Warnings
Ask A Doctor Before use if you have
Stop use and ask a doctor if
Pregnancy or breast feeding section
Keep out of reach of children
These highlights do not include all the information needed to use
- *
- Sections or subsections omitted from the full prescribing information are not listed.
- Active Ingredients
- These highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval
-
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
- Stop use and ask a doctor if
- Pregnancy or breast feeding section
- Keep out of reach of children
-
These highlights do not include all the information needed to use
Follow dosage below or use as directed by a doctor. Do not exceed 6 doses in a 24 hours period.
Adults and children 12 years and older 2 teaspoonfuls every 4 hours
Children 6 years to under 6 years 1 teaspoonful every 4 hours
Children 2 years to 6 years 1/2 teaspoonful every 4 hours
Children under 2 years Consult a doctor
- Other information
- Inactive Ingredients
- Questions or Comments?
- Safety Information
- Expiration Date information
- Principal Panel
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INGREDIENTS AND APPEARANCE
SORBUTUSS NR
sorbutuss liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68436-120 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 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength POTASSIUM CITRATE (UNII: EE90ONI6FF) Product Characteristics Color Score Shape Size Flavor ORANGE (with Sucralose) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68436-120-16 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/01/2007 Labeler - Dextrum Laboratories Inc. (186958810) Registrant - Teral Inc (186958810) Establishment Name Address ID/FEI Business Operations Dextrum Laboratories, Inc 007392322 manufacture(68436-120)
