FDA.reportPublic FDA data

Sorbutuss

Manufacturer
Dextrum Laboratories Inc. | Teral Inc | Dextrum Laboratories, Inc
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:28:37

Label at a glance#

ProductSorbutuss NR
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Storage and handling

Store at room temperature 15º-30º C (59º - 86º F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Each 7.5 mL. Contains (1 1/2 tsp)

Dextromethorphan HBr 15 mg......Antitussive

Glyceryl Guaiacolate 150 mg....Expectorant

Purpose Section

OTC - PURPOSE SECTION

Antitusive

Expectorant

These highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval

INDICATIONS & USAGE SECTION

  • 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.

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • Chronic cough that last such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • Cough that occurs with too much phlegm (mucus).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Cough last for more than 7 days comes back or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Pregnancy or breast feeding section

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In a case of overdose, get medical help or contact a Poison Control Center right away.

These highlights do not include all the information needed to use

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature 15º-30º C (59º - 86º F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Artificial and Natural Flavors, Glycerin, Methylparaben, Potassium Citrate, Propylparaben, Purified Water, Sorbitol and Sucralose

Questions or Comments?

OTC - QUESTIONS SECTION

Teral, Inc. (787) 383-2781 Fax (787) 284-9082

Safety Information

OTHER SAFETY INFORMATION

Do not accept if safety seal around bottle cap is broken or missing

Expiration Date information

SPL UNCLASSIFIED SECTION

Lot:

Exp:

Rev:12/06

Principal Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SorbutussSorbutuss

NDC 68436-120-16

Sorbutuss NR

Antitussive-Expectorant

Does Not Containt

Antihistamines

Decongestants

Sodium

With

Sucralose

Sugar Free Alcohol Free

Dye Free

Grape Flavor

16 oz. fl. oz. (474 mL)

Manufacture for

Teral, Inc.

Ponce, P.R. 00731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN8
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD8
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY8
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY8
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68436-120-162021-02-12C16284748780-19d75b9d0-6c3a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval OTC Monograph
68436-120-162020-01-31C16284748780-19d75b9d0-6c3a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval OTC Monograph

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68436-120-16SorbutussNR474 mL in 1 BOTTLE, PLASTICLIQUID4748

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68436-120-16ML - Milliliter68436-120ba80cd4d-7896-40cd-8164-62967b1a219d12016-05-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68436-12068436-120-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
POTASSIUM CITRATEEE90ONI6FFIACT
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sorbutuss NRSORBUTUSSDextrum Laboratories Inc.304f1d5a-218c-51ae-e054-00144ff88e882025-12-26WarningsExact identifier
ndc (package): 68436-120-16
ndc (product): 68436-120
ndc11 (package): 68436012016
spl id: 46dba920-03e1-9996-e063-6394a90ad9f8
spl set id: 304f1d5a-218c-51ae-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.