Label: TUSNEL DM PEDIATRIC- dextromethorphan, guiafenesin, pseudoephedrine hcl solution/ drops
- NDC Code(s): 54859-603-02
- 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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ACTIVE INGREDIENT
Active Ingredients in each 1 mL (dropperful) Purpose
Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant
Guaifenesin........................25mg................................................Expectorant
Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant
- PURPOSE
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WARNINGS
Warnings
Do not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, 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
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TUSNEL DM PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-603 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 2.5 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 (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:54859-603-02 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/01/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/1993 Labeler - Llorens Pharmaceutical International Division (037342305)