TRIPROLIDINE HYDROCHLORIDE- triprolidine hydrochloride liquid 
Rugby Laboratories

----------

TRIPROLIDINE HYDROCHLORIDE- triprolidine hydrochloride

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

AgeDose
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

PRINCIPAL DISPLAY PANEL
NDC 0536-1257-75
Rugby
Triprolidine HCl
Antihistamine
0.938mg/1mL
Bubblegum Liquid

TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1257
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE0.938 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1257-7530 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/09/201910/31/2024
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
MONARCH PCM, LLC080000294manufacture(0536-1257)

Revised: 1/2024
Document Id: 0e9b56a3-f6ee-fccf-e063-6394a90aade0
Set id: 38520245-603f-4d44-b467-8cfe1f15c850
Version: 3
Effective Time: 20240110
 
Rugby Laboratories