TRIPROLIDINE HYDROCHLORIDE- triprolidine hydrochloride liquid
Westminster Pharmaceuticals, 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.

----------

Triprolidine HCl

Drug Facts

Active ingredients (in each mL)

Triprolidine HCl 0.313 mg

Purpose

Antihistamine

Uses

temporarily relieves:
- runny nose
- sneezing
- itching of nose and throat
- itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Warnings

May cause excitability, especially in children

Do Not Use

if you or your children are taking sedatives or tranquilizers, without first consulting your doctor
with any other product containing triprolidine

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

When using this product

do not use more than directed
may cause drowsiness
avoid alcoholic drinks
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
symptoms do not improve within 7 days or are accompanied by a fever

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.

Directions

take every 4 to 6 hours
do not take more than 4 doses in 24 hours or as directed by a doctor
do not give more than directed or exceed the recommended daily dosage

Adults and children 12 years of age and over	8 mL
Children 6 to under 12 Years of age	4 mL
Children under 6 years of age	Ask a doctor

use only with enclosed dropper
do not use enclosed dropper for any other drug product

Other Information

Store at controlled room temperature 15˚-30˚C (59˚-86˚F)
Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose

Questions

Call: 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

NDC 69367-186-50

Triprolidine HCl

Each 1 mL contains:
Triprolidine HCl
0.313 mg

Antihistamine

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

(50 mL)

Westminster
Pharmaceuticals

TRIPROLIDINE HYDROCHLORIDE
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69367-186
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.313 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69367-186-50	1 in 1 CARTON	03/15/2018	10/18/2021
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	03/15/2018	10/18/2021

Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 3/2018

Document Id: d78a7f8f-1904-406a-a5f4-b05c8208d49b

Set id: ad89a8ee-6649-4320-820c-e066b087bab2

Version: 4

Effective Time: 20180314

Westminster Pharmaceuticals, LLC