Tusnel
- Manufacturer
- Llorens Pharmaceutical International Division
- Effective date
- 2025-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:51:10
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
Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant
Guaifenesin .......................................................... 100 mg .................. Expectorant
Pseudoephedrine HCl ............................................. 30 mg .......... Nasal Decongestant
OTC - PURPOSE SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves: nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis, cough due to minor bronchial irritation as may occur with the common cold
- temporarily restores freer breathing through the nose
- calms the cough control center and relieves coughing
WARNINGS SECTION
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.
When using this product
do nol exceed recommended dosage
• may cause or aggravate constipation
OTC - DO NOT USE SECTION
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. chronic pulmonary disease or shortness of breath, or who are taking other drugs
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless. symptoms do not get better within 7 days or are accompanied by fever. cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical helpor contact a Poison Control Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
Directions: Follow dosage chartDosage may be repeated every 6 hours. Not to exceed 4 doses in 24-hours. Giving a higher dose
than recommended by a doctor could result in serious side effects for your child. A special measuring
device should be used to give an accurate dose of this product to children under 6 years of age.
| Age | Weight | Dose |
| children 12 years of age and over | 95 lbs and up | Take 2 teaspoonfuls (10 mL)
every 6 hours |
| Children 6 to under 12 years of age | 45 lbs to under 95 lbs | Take 1 teaspoonful (5mL)
every 6 hours |
| Children under 6 years of age | under 45 lbs | ask a doctor |
INDICATIONS & USAGE SECTION
Other information
- store at controlled room temperature 20°- 25°C (68°- 77°F)
- Each teaspoonful (5 ml) contains: sodium 2mg
- Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
INACTIVE INGREDIENT SECTION
Inactive ingredientsaspartame, citric acid, glycerine, methylparaben,
natural and artificial flavors, potassium citrate, potassium sorbate,
propylene glycol, propylparaben, purified water.
OTC - QUESTIONS SECTION
Questions or Comments?1-866-595-5598
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0354859520166 | GTIN-13: 0354859520166 EAN-13: 0354859520166 GTIN-12: 354859520166 UPC-A: 354859520166 GTIN storage (14 digits): 00354859520166 | tusnelclabel.jpg |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54859-520-16 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-0fbb-f424-e053-dadaa90a57ce | Llorens- Tusnel CV 520 |
| 54859-520-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0fbb-f424-e053-dadaa90a57ce | Llorens- Tusnel CV 520 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-520-16 | ML - Milliliter | 54859-520 | 069d8557-fbea-4ab7-8869-f1c9af7596ee | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | 2 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 2 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | 2 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | 2 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | 2 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Tusnel C
- Codeine Phosphate, Guiafenesin, Pseudoephedrine HCl
- FD&C RED NO. 40
- CITRIC ACID MONOHYDRATE
- SODIUM BENZOATE
- SACCHARIN SODIUM
- SORBITOL
- PROPYLENE GLYCOL
- WATER
- CODEINE PHOSPHATE
- CODEINE ANHYDROUS
- GUAIFENESIN
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54859-520 | 54859-520-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| CODEINE PHOSPHATE | GSL05Y1MN6 | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | 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 |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ENEMA / RECTAL | 60 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CONCENTRATE / ORAL | 5.3 mg/1ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | EMULSION / TOPICAL | 0.11 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / IONTOPHORESIS | 0.02 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | ELIXIR / ORAL | 100 mg/5ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / RESPIRATORY (INHALATION) | 0.03 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAMUSCULAR | 864 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, COATED / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE, EXTENDED RELEASE / ORAL | 101 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EXTENDED RELEASE / ORAL | 45 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM, EXTENDED RELEASE / TRANSDERMAL | 1.38 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / NASAL | 25 mg/1ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / BUCCAL | 0.4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 385 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / BUCCAL | 5110 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / SUBLINGUAL | 24 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v |
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 |
|---|---|---|---|---|---|---|
| 5242a3ad-4bad-bf59-e063-6394a90ac6e0 | 403935ac-5111-4f8b-80ae-1bd47ae774c7 | 2026-05-20 | Warnings | 403935ac-5111-4f8b-80ae-1bd47ae774c7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
