TRIPROLIDINE HYDROCHLORIDE liquid

Triprolidine Hydrochloride by

Drug Labeling and Warnings

Triprolidine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Westminster Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each mL)

Triprolidine HCl 0.625 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
• use only with enclosed dropper
• do not use enclosed dropper for any other drug product

• Adults and children 12 years of age and over: 4 mL (2.5 mg)
• Children 6 to under 12 years of age: 2 mL (1.25 mg)
• Children under 6 years of age: ask a doctor

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

Banana flavor, citric acid, FD&C Red #40, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, strawberry flavor, sucralose

Questions?

Call 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC: 69367-185-30

Triprolidine HCl

Each 1 mL contains:

Triprolidine HCl
0.625 mg

Antihistamine

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

Strawberry-banana Flavor
1 oz. (30 mL)

Westminster
Pharmaceuticals

INGREDIENTS AND APPEARANCE

TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69367-185
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.625 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY, BANANA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69367-185-30	1 in 1 CARTON	04/12/2018
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/12/2018

Labeler - Westminster Pharmaceuticals, LLC (079516651)