NDC | 54859-502-06, 54859-502-10, 54859-502-16 |
Set ID | 805dc611-355a-4af5-bf19-464c3290c5c6 |
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........15mg..................................................Cough Suppressant
Guaifenesin........................200mg................................................Expectorant
Pseudoephedrine HCl..........30mg..................................................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.Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of prostate gland
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Uses:
- temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
- helps control reflex that causes coughing
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TUSNEL
dextromethorphan, guiafenesin, pseudoephedrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-502 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-502-06 178 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2006 2 NDC:54859-502-16 474 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2006 3 NDC:54859-502-10 3786 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)