NDC | 54859-544-04, 54859-544-16 |
Set ID | 82f447f6-4f1b-4f56-9d7d-ea02adeea88c |
Category | HUMAN OTC DRUG LABEL |
Packager | Llorens Pharmaceutical International Division |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
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ACTIVE INGREDIENT
Active Ingredients(in each 5 ml tsp.) Purpose
Dextromethorphan HBr........5mg..................................................Cough Suppressant
Guaifenesin........................50mg................................................Expectorant
Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant
- PURPOSE
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WARNINGS
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. -
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
Stop use and ask a doctor if
- 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.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions Do not exceed more than 4 doses in any 24-hour period
or as directed by a doctor.Age Weight Dose Children 6 to under
12 years of age45 lbs to under
95 lbsTake 2 teaspoonfuls (10 mL)
every 4 to 6 hoursChildren 2 to under
6 years of age25 lbs to under
45 lbsTake 1 teaspoonful (5mL)
every 4 to 6 hoursChildren under 2 years of age Under 25 lbs ask a doctor - INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TUSNEL PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-544 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 50 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-544-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2006 2 NDC:54859-544-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2006 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)