CHILDRENS PEDIACLEAR 8- pyrilamine maleate liquid 
GM Pharmaceuticals, INC

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.

----------

Childrens PediaClear 8

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

■ mL= milliliter
■ use enclosed 15 mL dose cup and keep with product
■ children 6 to under 12 years: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor
■ children under 6 years of age: consult a doctor.

Other information

■ each 15 mL contains: Sodium 6 mg
■ read all product information before using
■ this packaging is child-resistant
■ 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)

PDP1

Drug Facts

CHILDRENS PEDIACLEAR 8 
pyrilamine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-770
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE12.5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-770-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/19/2019
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 8/2023
Document Id: 02a81b7a-6679-87b8-e063-6294a90a9bb9
Set id: 8e524967-d01c-4c93-9198-c42f15fe3fe0
Version: 7
Effective Time: 20230811
 
GM Pharmaceuticals, INC