TRIPROLIDINE HYDROCHLORIDE by Monarch PCM, LLC Triprolidine HCI

Drug Details [pdf]

TRIPROLIDINE HYDROCHLORIDE- triprolidine hydrochloride liquid
Monarch PCM, LLC

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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Triprolidine HCI

Drug Facts

Active ingredients (in each 1 mL dropperful)

Triprolidine HCl 0.938 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

runny nose
sneezing
itching of the nose or throat
itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if the child has

a breathing problem such as emphysema or chronic bronchitis
glaucoma

Ask a doctor before use if the child is taking sedatives or tranquilizers

When using this product

excitability may occur, especially in children
may cause drowsiness
sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

new symptoms occur

Keep out of the reach of children.

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

Directions

Do not exceed recommended dosage.

■ use only with enclosed dropper
■ do not use enclosed dropper for any other drug product
■ mL= milliliter
■ Professional Labeling: Take under guidance of Health Professionals.

AGE	DOSE
Childen 4 to under 6 years of age:	1 dropperful (1.0 mL) every 4 to 6 hours, not to exceed 4 doses (4.0 mL) in 24 hours, or as directed by a Doctor.
Children 2 to under 4 years of age	⅔ dropperful (0.67 mL) every 4 to 6 hours, not to exceed 4 doses (2.67 mL) in 24 hours, or as directed by a Doctor.
Infants 4 months to under 2 years of age	⅓ dropperful (0.33 mL) every 4 to 6 hours, not to exceed 4 doses (1.33 mL) in 24 hours, or as directed by a Doctor.

Other Information

store at room temperature 15-30°C (59-86°F)
Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

Inactive ingredients

bubble gum flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium
sorbate, propylene glycol, propylparaben, purified water, sucralose

Questions? Comments?

Call 1-844-696-6627 9 a.m. - 5 p.m. CST.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Do not use if foil seal
under cap is missing or
broken.
Usual Dosage:
See attached labeling for
complete product
information.
store at °30-15C
(°86-68F)

KEEP OUT OF REACH
OF CHILDREN.

This product
includes professional
labeling for medical
practioners only.

Manufactured by:
Monarch PCM, LLC.
Fort Worth, TX 76118

PDP

Drug Facts

TRIPROLIDINE HYDROCHLORIDE
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70154-204
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.938 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
AMMONIUM GLYCYRRHIZINATE TRIHYDRATE (UNII: 78NEL3149I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70154-204-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M012	08/19/2019	10/31/2024

Labeler - Monarch PCM, LLC (080000294)

Revised: 1/2023

Document Id: 911fd39d-9c95-52ae-e053-2a95a90a13f3

Set id: 91206c6e-f122-6a66-e053-2995a90afdc9

Version: 1

Effective Time: 20230101