Tusnel Pediatric Drops
- Manufacturer
- LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- Effective date
- 2025-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:30:43
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients in each (1 mL)
Guaifenesin 25 mg
Phenylephrine HCl 1.25 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
Nasal Decongestant
INDICATIONS & USAGE SECTION
Uses
- Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
- Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.
WARNINGS SECTION
Warnings
Do not use in child whos is 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 child's prescription drug contains an MAOI: ask your doctor or pharmacist before giving this product.
Ask a doctor before use if your child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a cough that occurs with too much phlegm
- a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
When using this product
- do not exceed the recommended dosage.
Stop use and ask doctor if
- nervousness, dizziness or sleeplessness occurs
- symptoms do not get better within 7 days or accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.
| Age | Weight | Dose |
| Children 2 to under 6 years of age | 24-47 lbs | Take 2 mL every 4-6 hours |
| Children under 2 years of age | Under 24 lbs | Ask a doctor |
INACTIVE INGREDIENT SECTION
Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.
OTC - QUESTIONS SECTION
Questions or Comments? 1-866-595-5598
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2268063 | guaiFENesin 25 MG / phenylephrine HCl 1.25 MG in 1 mL Oral Solution | PSN | 4 |
| 2268063 | guaifenesin 25 MG/ML / phenylephrine hydrochloride 1.25 MG/ML Oral Solution | SCD | 4 |
| 2268063 | guaifenesin 25 MG / phenylephrine hydrochloride 1.25 MG per 1 mL Oral Solution | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-605-01 | Tusnel Pediatric Drops | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 4 |
Products#
Every source-derived product name is available through these pages.
- Tusnel Pediatric Drops
- Guaifenesin, Phenylephrine HCl
- ANHYDROUS CITRIC ACID
- GLYCERIN
- METHYLPARABEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54859-605 | 54859-605-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
Source Document#
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 Pediatric Drops | GUAIFENESIN, PHENYLEPHRINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7 | 2025-12-31 | Warnings | 54859-605-01 54859-605 54859060501 47462c1c-38e8-e1af-e063-6394a90a4955 dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
