TRIPONEL- dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

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.

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Active Ingredients (in each 5 mL)

Dextromethorphan HBr 15 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg

Purpose

Cough Suppressant

Nasal Decongestant

Antihistamine

Uses

Warnings

Do not use if you are taking a 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 you r prescirption drug contains an MAOI, ask a doctor or pharmacist before using this product.

Ask a doctor before use if you have 

Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs. 

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Direcations: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

 Age Dose
 Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 6 hours
 Children 6 to under 12 years of age Take 1 teaspoonful (5 mL) every 6 hours
 Children under 6 Ask a docotor

Inactive ingredients: artificial flavor, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

Questions or Comments? 1-866-595-5598

Triponel

TRIPONEL 
dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-508
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 5 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-508-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2019
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Revised: 12/2019
Document Id: bce65e4f-a4b1-4b28-b6f9-ac1f614dec82
Set id: cc774d33-96ce-4992-ad30-3cb03b0d119d
Version: 1
Effective Time: 20191229
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION