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NDC 54859-0605-01 Tusnel Pediatric Drops 25; 1.25 mg/mL; mg/mL Details
Tusnel Pediatric Drops 25; 1.25 mg/mL; mg/mL
Tusnel Pediatric Drops is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. The primary component is GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 54859-0605-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 54859-0605-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
NDC | 54859-0605 |
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Product ID | 54859-605_47dff372-3f9d-48bc-86a3-5d0ee6b3d68e |
Associated GPIs | 43996202100948 |
GCN Sequence Number | 081506 |
GCN Sequence Number Description | guaifenesin/phenylephrine HCl DROPS 25-1.25/ML ORAL |
HIC3 | B4W |
HIC3 Description | DECONGESTANT-EXPECTORANT COMBINATIONS |
GCN | 48644 |
HICL Sequence Number | 000250 |
HICL Sequence Number Description | GUAIFENESIN/PHENYLEPHRINE HCL |
Brand/Generic | Brand |
Proprietary Name | Tusnel Pediatric Drops |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Guaifenesin, Phenylephrine HCl |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION/ DROPS |
Route | ORAL |
Active Ingredient Strength | 25; 1.25 |
Active Ingredient Units | mg/mL; mg/mL |
Substance Name | GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
Labeler Name | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 54859-0605-01 (54859060501)
NDC Package Code | 54859-605-01 |
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Billing NDC | 54859060501 |
Package | 30 mL in 1 BOTTLE, DROPPER (54859-605-01) |
Marketing Start Date | 2019-08-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7 Details
SPL UNCLASSIFIED SECTION
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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.
SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
TUSNEL PEDIATRIC DROPS
guaifenesin, phenylephrine hcl solution/ drops |
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Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) |