TRIPONEL- dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid

Triponel by

Drug Labeling and Warnings

Triponel by is a Otc medication manufactured, distributed, or labeled by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL)

Dextromethorphan HBr 15 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg

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 symptomes due to hay fever or ther upper respiratory allergies
• runny nose
• itchy, watery eyes
• sneexing
• itching of the nose or throat

WARNINGS

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 

• 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. 

When using this product

• do not exceed recommended dose
• excitability may occur, especially in children
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness dizziness, or sleeplessness occurs
• cough lasts for more than 7 days, comes back, or occurs with a beer, 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 professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 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, phenylephrine hcl, triprolidine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-508
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 5 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 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: 54859-508-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2019

Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)