FDA.reportPublic FDA data

TRIPROLIDINE HYDROCHLORIDE- triprolidine HCl syrup 5mL

Manufacturer
Rugby Laboratories
Effective date
2022-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:13:32

Label at a glance#

ProductTRIPROLIDINE HYDROCHLORIDE
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rugby Laboratories  Triprolidine HCl 2.5mg/5mL Bubblegum Liquid 

NDC: 0536-1258-59

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)

Triprolidine HCI 2.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ 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

OTC - ASK DOCTOR SECTION

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

■ new symptoms occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)      

Directions

DOSAGE & ADMINISTRATION SECTION

AgeDose
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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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 LiquidPRINCIPAL 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 LiquidPRINCIPAL DISPLAY PANEL NDC 0536-1258-59 Rugby Triprolidine HCl 2.5mg/5mL Bubblegum Liquid

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1258-59ML - Milliliter0536-12589f0894bc-86d7-457c-8c90-6cb23dfa499812020-04-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12580536-1258-59

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d5f4232f-0e78-f299-e053-2a95a90a0d3f7cde1cec-6c75-477b-8460-2bf2227b66a42022-01-19WarningsExact identifier
spl id: d5f4232f-0e78-f299-e053-2a95a90a0d3f
spl set id: 7cde1cec-6c75-477b-8460-2bf2227b66a4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.