Label: TUSNEL PEDIATRIC- dextromethorphan, guiafenesin, pseudoephedrine hcl liquid
- NDC Code(s): 54859-544-04, 54859-544-16
- Packager: Llorens Pharmaceutical International Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 23, 2020
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- Official Label (Printer Friendly)
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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)
