TRIPROLIDINE HYDROCHLORIDE liquid

Triprolidine Hydrochloride by

Drug Labeling and Warnings

Triprolidine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Woodward Pharma Services 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 your child has

• 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 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 oral syringe
• do not use enclosed oral syringe 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 20°-25°C (68°-77°F)
• Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Banana flavor, citric acid, FD&C red #40, glycerin, magnasweet, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, strawberry flavor and sucralose

Questions or Comments

Please Call 1-888-514-4727

Distributed by:
Woodward Pharma Services LLC
Birmingham, MI 48009

Professional Labeling

Take under guidance of Health Professionals.

Children 4 months to under 2 years of age	0.5 mL (0.313 mg)
Children 2 to under 4 years of age	1 mL (0.625 mg)
Children 4 to under 6 years of age	1.5 mL (0.938 mg)

Take every 6 hours. Do not exceed 4 doses in 24 hours.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC: 69784-102-01

Triprolidine Hydrochloride Oral Solution

Each 1 mL contains:
Triprolidine HCl
0.625 mg

Antihistamine

1 oz. (30 mL)

Strawberry-banana Flavor

Tamper Evident: Do not use if imprinted cap seal is broken or missing

WOODWARD PHARMA

INGREDIENTS AND APPEARANCE

TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69784-102
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69784-102-01	1 in 1 CARTON	10/10/2016
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	10/10/2016

Labeler - Woodward Pharma Services LLC (026749066)