ALLERDINE- triprolidine hydrochloride liquid

Allerdine by

Drug Labeling and Warnings

Allerdine 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: 69784-803-01

ALLERDINE

Strawberry Banana Flavored Antihistamine

Triprolidine Hydrochloride Oral Solution

Each 1 mL contains: 0.625 mg Triprolidine HCl

INGREDIENTS AND APPEARANCE

ALLERDINE 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69784-803
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: 69784-803-01	1 in 1 CARTON	06/09/2018
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	06/09/2018

Labeler - Woodward Pharma Services LLC (026749066)