TRIPROLIDINE HYDROCHLORIDE liquid

TRIPROLIDINE HYDROCHLORIDE by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rugby Laboratories  Triprolidine HCl 2.5mg/5mL Bubblegum Liquid 

NDC: 0536-1258-59

Drug Facts

Active ingredient

(in each 5 mL teaspoonful)

Triprolidine HCI 2.5 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

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma      

■ trouble urinating due to an enlarged prostate gland

Ask a doctor before use you are taking sedatives or tranquilizers

When using this product

■ excitability may occur, especially in children

■ may cause drowsiness

■ 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

• Age: Dose
• adults and children 12 years of age and older: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor
• children 6 to under 12 years of age: ½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoonfuls (10 mL) 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

■ dispense in a tight, light-resistant container with a child-resistant cap.

Inactive ingredients

bubble gum flavor, citric acid, glycerin, monoammonium glycyrrhizinate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions or comments?

Call 1-800-645-2158

PRINCIPAL DISPLAY PANEL

NDC: 0536-1258-59
Rugby
Triprolidine HCl
2.5mg/5mL
Bubblegum Liquid

INGREDIENTS AND APPEARANCE

TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1258
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
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: 0536-1258-59	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2019

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

Labeler - Rugby Laboratories (079246066)