OTC - ACTIVE INGREDIENT SECTION
Guaifenesin 200 mg / 5 mL – Purpose: Expectorant
Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive
Guaifenesin 200 mg / 5 mL – Purpose: Expectorant
Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive
Artificial and natural flavors, glycerin, hydroxyethylcellulose, menthol, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, and sucralose.
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.
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.
Expectorant and Antitussive (cough suppressant)
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.
In case of accidental overdose, seek the advice of a health professional or contact a Poison Control Center immediately.
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.
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.
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
1 FL. OZ (30 mL) NDC: 12539-555-01
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1147924 | dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 5 mL Oral Solution | PSN | 2 |
| 1147924 | dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML Oral Solution | SCD | 2 |
| 1147924 | dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG per 5 ML Oral Solution | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12539-555-01 | NeoTuss S/FGrape-Menthol Flavor | 30 mL in 1 BOTTLE | LIQUID | 30 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 12539-555-16 | ML - Milliliter | 12539-555 | 50d9fbb2-fd78-4385-a5fc-7ee9d9b9a058 | 1 | 2025-05-14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 12539-555 | 12539-555-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROXYETHYLCELLULOSE | T4V6TWG28D | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| SORBITOL | 506T60A25R | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3df82c-1926-5238-e063-6294a90a7bbf | 2025-12-18 | Warnings | 12539-555-01 12539-555 12539055501 463c3e8f-7445-efdd-e063-6394a90a660b 2f3df82c-1926-5238-e063-6294a90a7bbf |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fac3425-32f0-38d6-e063-6394a90a6e7a | 2025-12-18 | Warnings | 12539-555 |
Adverse event summaries are temporarily unavailable. Other product information remains available.