Tusnel Diabetic
- Manufacturer
- LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- Effective date
- 2025-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:29:15
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients ( in each 5 mL tsp.) Purpose
Dextromethorphan HBr USP........ 10 mg ................................. Cough Suppressant
Guaifenesin USP ............. 100 mg ......................................... Expectorant
OTC - PURPOSE SECTION
Purpose
Cough Suppressant
Expectorant
WARNINGS SECTION
Warnings
Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if 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 giving this product.
OTC - DO NOT USE SECTION
Ask a doctor before use if you have
- a cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could b a sign of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
Directions
Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.
| Age | Dose |
| Adults and children 12 years of age and over | 2 teaspoonfuls (10 mL) every 4 hours |
| Under 2 years of age | Do not use |
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
INACTIVE INGREDIENT SECTION
Inactive Ingredients: anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate and sucralose.
OTC - QUESTIONS SECTION
Questions or Comments?1-866-595-5598
Distributed By: Llorens International Division, Miami FL 33165
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 7 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 7 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 7 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 7 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 7 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0354859505163 | GTIN-13: 0354859505163 EAN-13: 0354859505163 GTIN-12: 354859505163 UPC-A: 354859505163 GTIN storage (14 digits): 00354859505163 | TusnelDia505.jpg |
DailyMed Product Concepts#
| 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 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54859-505-04 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-4255-f424-e053-dadaa90a57ce | Llorens-TusnelDiabetic 505 |
| 54859-505-16 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-4255-f424-e053-dadaa90a57ce | Llorens-TusnelDiabetic 505 |
| 54859-505-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4255-f424-e053-dadaa90a57ce | Llorens-TusnelDiabetic 505 |
| 54859-505-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4255-f424-e053-dadaa90a57ce | Llorens-TusnelDiabetic 505 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-505-04 | Tusnel Diabetic | 118 mL in 1 BOTTLE | LIQUID | 118 | 7 | |
| 54859-505-16 | Tusnel Diabetic | 472 mL in 1 BOTTLE | LIQUID | 472 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-505-04 | ML - Milliliter | 54859-505 | c457a812-04f0-43fe-989e-74cbee67594f | 1 | 2012-07-24 |
| 54859-505-16 | ML - Milliliter | 54859-505 | 91be4c5f-d3cd-45dd-968d-a2ba0d8922c7 | 1 | 2020-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Tusnel Diabetic
- Dextromethorphan, Guaifenesin
- SUCRALOSE
- CITRIC ACID MONOHYDRATE
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54859-505 | 54859-505-04, 54859-505-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING / ORAL | 180 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SYRUP / ORAL | 0.63 mg/5ml | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SOLUTION / ORAL | 40 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SYRUP / ORAL | 0.63 mg/5ml | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET / ORAL | 87 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE / ORAL | 195 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING / ORAL | 180 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE / ORAL | 195 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SOLUTION / ORAL | 233 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER / ORAL | 63 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, EFFERVESCENT / ORAL | 30 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, EFFERVESCENT / ORAL | 30 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET / ORAL | 87 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | LOZENGE / ORAL | 136 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, FOR SUSPENSION / ORAL | 420 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CAPSULE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SOLUTION / ORAL | 233 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SUSPENSION / ORAL | 23 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SUSPENSION / ORAL | 23 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING / ORAL | 180 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SOLUTION / ORAL | 40 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tusnel Diabetic | DEXTROMETHORPHAN, GUAIFENESIN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 66b3c094-809e-4d2c-bc15-46563de685cb | 2025-12-29 | Warnings | 54859-505-16 54859-505-04 54859-505 54859050504 54859050516 471f18f8-553e-41f9-e063-6394a90ae51e 66b3c094-809e-4d2c-bc15-46563de685cb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
