TRIPROLIDINE HYDROCHLORIDE- triprolidine hydrochloride liquid
Rugby Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TRIPROLIDINE HYDROCHLORIDE- triprolidine HCl syrup 5mL

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

PRINCIPAL DISPLAY PANEL
NDC 0536-1258-59
Rugby
Triprolidine HCl
2.5mg/5mL
Bubblegum Liquid

TRIPROLIDINE HYDROCHLORIDE
triprolidine hydrochloride liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1258-59	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/11/2019	04/30/2022

Labeler - Rugby Laboratories (079246066)

Revised: 1/2022

Document Id: d5f4232f-0e78-f299-e053-2a95a90a0d3f

Set id: 7cde1cec-6c75-477b-8460-2bf2227b66a4

Version: 2

Effective Time: 20220119

Rugby Laboratories