NDC | 54859-602-02 |
Set ID | f9fe6883-6e10-4851-8acb-a6df6e862375 |
Category | HUMAN OTC DRUG LABEL |
Packager | Llorens Pharmaceutical International Division |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Warnings
Do not use in child who 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 a doctor or pharmacist before giving this product. -
DO NOT USE
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 (mucus)
- a persistent or chronic cough such as occurs with asthma
When using this product
- do not exceed recommended dosage
- nervousness, dizziness or sleeplessness occurs
- symptoms do not get better within 7 days or accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.
- heart disease
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TUSNEL PEDIATRIC
guiafenesin, pseudoephedrine hcl solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-602 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 25 mg in 1 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 7.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-602-02 60 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2006 Labeler - Llorens Pharmaceutical International Division (037342305)