CHILDRENS PEDIACLEAR PD- triprolidine hydrochloride liquid

Childrens PediaClear PD by

Drug Labeling and Warnings

Childrens PediaClear PD by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CHILDREN’S PEDIACLEAR PD

NDC: 58809-651-50

Drug Facts

Active ingredients (in each 2 mL)

Triprolidine HCI 1.25 mg

Purpose

Antihistamine

Uses

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

■ runny nose       ■ itching of the nose or throat

■ sneezing       ■ itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if the child has

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

Ask a doctor before use if the child is

taking sedatives or tranquilizers

When using this product

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

■ new symptoms occur

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

■ use only with enclosed dropper

■ do not use dropper for any other drug product

■ mL= milliliter

■ Professional Labeling: Take under guidance of health professionals.

children 6 to under 12 years of age:       2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

     

children 4 to under 6 years of age:       1.5 mL ever 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

           

children 2 to under 4 years of age:       1 mL ever 6 hours, not to exceed 4 doses in 24 hours

or as directed by a doctor.

infants 4 months to under 2 years of age: .5 mL every 6 hours, not to exceed 4 doses in 24 hours or as directed by a doctor.

Other information

■ read all product information before using

■ store at room temperature 20-30°C (68-86°F)

Inactive ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions or comments?

Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76015

PRINCIPAL DISPLAY PANEL

NDC: 58809-651-50
Children’s
PediaClear
PD
Drops
1.69 fl oz (50 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS PEDIACLEAR PD 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-651
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 mg  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-651-50	50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/01/2019

Labeler - GM Pharmaceuticals, INC (793000860)