Childrens Pediaclear 8

Drug Facts

Composition & Product

Active Ingredients

Pyrilamine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-08-19

Medication Information

Purpose

Antihistamine

Description

CHILDRENS PEDIACLEAR 8 NDC: 58809-770-08

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.

Section 42229-5

CHILDRENS PEDIACLEAR 8

NDC: 58809-770-08

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)

Active Ingredients

(in each 15 mL)

Pyrilamine Maleate 12.5 mg

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)

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.

Ask A Doctor Before Use If the Child Is

taking sedatives or tranquilizers

Ask A Doctor Before Use If the Child Has

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

Structured Label Content

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.

Section 42229-5 (42229-5)

CHILDRENS PEDIACLEAR 8

NDC: 58809-770-08

Purpose

Antihistamine

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 (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)

Active Ingredients (Active ingredients)

(in each 15 mL)

Pyrilamine Maleate 12.5 mg

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58809-770-08

Children’s

PediaClear

8 Eight

8 fl oz (237 mL)

When Using This Product (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 (Stop use and ask a doctor if)

new symptoms occur

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If the Child Is (Ask a doctor before use if the child is)

taking sedatives or tranquilizers

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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