NeoTuss S/F

Manufacturer
DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | DEXTRUM LABORATORIES INC
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:26:06

Label at a glance#

ProductNeoTuss S/F Grape-Menthol Flavor
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 mg / 5 mL – Purpose: Expectorant

Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive

INACTIVE INGREDIENT SECTION

Artificial and natural flavors, glycerin, hydroxyethylcellulose, menthol, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, and sucralose.

INDICATIONS & USAGE SECTION

Temporarily relieves cough due to minor bronchial irritations as may occur with the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Adults and children over 12 years of age: Oral dose in one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.

Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.

Children under 6 years of age: Only as directed by a physician.

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age: Oral dose in one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.

Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.

Children under 6 years of age: Only as directed by a physician.

OTC - PURPOSE SECTION

Expectorant and Antitussive (cough suppressant)

OTC - WHEN USING SECTION

Temporarily relieves cough due to minor bronchial irritations as may occur with the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek the advice of a health professional or contact a Poison Control Center immediately.

WARNINGS SECTION

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician.

Do not take this product for persistent cough or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician.

OTC - STOP USE 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 are uncertain whether your prescription drug contains a MAOI, consult a health professional before taking this product.

If pregnant or breast-feeding, ask a health professional before using this product.

OTHER SAFETY INFORMATION

Shake well before use.

Do not use this product if the seal is torn, broken or missing.

Pharmacist: Preserve and dispense in tight, light-resistant containers as defined in the USP.

Store between 15°-30°C (59°-86°F).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel

1 FL. OZ (30 mL) NDC: 12539-555-01

NeoTUSS S/F labelNeoTUSS S/F label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147924dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 5 mL Oral SolutionPSN2
1147924dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML Oral SolutionSCD2
1147924dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG per 5 ML Oral SolutionSY2

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12539-555-01NeoTuss S/FGrape-Menthol Flavor30 mL in 1 BOTTLELIQUID302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12539-555-16ML - Milliliter12539-55550d9fbb2-fd78-4385-a5fc-7ee9d9b9a05812025-05-14

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12539-55512539-555-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3df82c-1926-5238-e063-6294a90a7bbf2025-12-18WarningsExact identifier
ndc (package): 12539-555-01
ndc (product): 12539-555
ndc11 (package): 12539055501
spl id: 463c3e8f-7445-efdd-e063-6394a90a660b
spl set id: 2f3df82c-1926-5238-e063-6294a90a7bbf
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fac3425-32f0-38d6-e063-6394a90a6e7a2025-12-18WarningsExact identifier
ndc (product): 12539-555

Reported adverse events (FAERS/openFDA)#

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