CHILDRENS PEDIACLEAR 8- pyrilamine maleate liquid

Childrens PediaClear 8 by

Drug Labeling and Warnings

Childrens PediaClear 8 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

CHILDRENS PEDIACLEAR 8

NDC: 58809-770-08

Active ingredients

 (in each 15 mL)

Pyrilamine Maleate 12.5 mg

Purpose

Antihistamine

Uses

■ temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

Warnings

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

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase drowsiness

■ excitability may occur, especially in children

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 dose cup and keep with product

■ mL= milliliter

■ professional labeling: for use under guidance of health professional only children 6 to under 12 years of age: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours. children 2 to under 6 years of age:15 mL (1 dose cup) every 6 to 8 hours, not to exceed 4 doses in 24 hours.

Other information

■ each 15 mL contains: Sodium 6 mg

■ 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, sorbitol, sucralose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 58809-770-08
Children’s
PediaClear
8 Eight
8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS PEDIACLEAR 8 
pyrilamine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-770
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	12.5 mg  in 15 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)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-770-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/25/2019

Labeler - GM Pharmaceuticals, INC (793000860)