Label: TRIPONEL- dextromethorphan hbr, pseufoephedrine hcl, triprolidine hcl liquid
- NDC Code(s): 54859-514-16
- Packager: Llorens Pharmaceutical International Division, Inc.
- 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.
Updated December 23, 2020
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- ACTIVE INGREDIENT
INDICATIONS & USAGE
- helps to control the reflex that causes coughing
- temporarily relieves nasal congestion due to common cold, hay fever, or other upper respiratory allergies (allergic: rhinitis)
- temporarily relieves these symptoms due to hay fever or upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
Do not use if you are taking a monoamine oxidase inhibitor (MAOI) (certain drugs for drepssion, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your presciption drug conatins an MAOI, ask a doctor or pharmacist before using this product.
Ask a doctor before use if you have
- heart disaese
- high blood pressure
- thyroid disease
- difficulty in urination due to an enlargment of the 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, transquilizers or drugs for depression or MAOI drugs.
When using this product
- do not exceed recommended dose
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedative and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machiney
Stop use and ask a doctor if
- nervoisness, dizziness or sleeplessness occurs
- 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dextromethorphan hbr, pseufoephedrine hcl, triprolidine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-514 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 PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) 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:54859-514-16 474 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2018 Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)