TRIPONEL- dextromethorphan hbr, pseufoephedrine hcl, triprolidine hcl liquid

Triponel by

Drug Labeling and Warnings

Triponel by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Dextromethorphan HBr

Pseudoephedrine HCl

Triprolidine HCl

PURPOSE

Purpose

Cough Suppressant

Nasal Decongestant

Antihistamine

INDICATIONS & USAGE

Uses

• 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
• sneezing
• itching of the nose or throat

WARNINGS

Warnings

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
• diabetes
• 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

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions: 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 (5mL) every 6 hours
• Children under 6: Ask a doctor

INACTIVE INGREDIENT

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

QUESTIONS

Questions or Comments? 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPONEL 
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)