TRIPROLIDINE HYDROCHLORIDE liquid

TRIPROLIDINE HYDROCHLORIDE by

Drug Labeling and Warnings

TRIPROLIDINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, MONARCH PCM, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rugby Laboratories Triprolidine HCl 0.938mg/1mL Bubblegum Liquid

NDC: 0536-1257-75

Drug Facts

Active ingredient

Purpose

(in each 1 mL dropperful)

Triprolidine HCI 0.938 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you are

taking sedatives or tranquilizers

When using this product

■ may cause drowsiness  

■ excitability may occur, especially in children

■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

■ avoid alcoholic beverages

■ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

■ new symptoms occur

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. (1-800-222-1222)

Directions

do not exceed recommended dosage.

■ use only with enclosed dropper

■ do not use enclosed dropper for any other drug product

• Age: Dose
• adult and children 12 year of age or older: 2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams) in 24 hours, or as directed by a doctor.
• children 6 to under 12 years of age: 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams) in 24 hours, or as directed by a doctor.
• children under 6 years of age: consult a doctor

Other information

■ this packaging is child-resistant.

■ store at room temperature 15°-30°C (59°-86°F)

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

Inactive ingredients

bubble gum flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose

Questions or comments?

Call 1-800-645-2158.

PRINCIPAL DISPLAY PANEL

NDC: 0536-1257-75

Rugby
Triprolidine HCl
Antihistamine
0.938mg/1mL
Bubblegum Liquid

INGREDIENTS AND APPEARANCE

TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1257
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.938 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1257-75	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/09/2019

Labeler - Rugby Laboratories (079246066)