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 0.313 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

INGREDIENTS AND APPEARANCE

TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69367-186-50	1 in 1 CARTON	03/15/2018
1		50 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	03/15/2018

Labeler - Westminster Pharmaceuticals, LLC (079516651)