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

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.

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

■ 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

Description

CHILDRENS PEDIACLEAR 8 NDC: 58809-770-08

Principal Display Panel

NDC 58809-770-08

Children’s

PediaClear

8 Eight

8 fl oz (237 mL)

Section 42229-5

CHILDRENS PEDIACLEAR 8

NDC: 58809-770-08

Active Ingredients

(in each 15 mL)

Pyrilamine Maleate 12.5 mg

Questions Or Comments?

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

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.

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)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58809-770-08

Children’s

PediaClear

8 Eight

8 fl oz (237 mL)

Section 42229-5 (42229-5)

CHILDRENS PEDIACLEAR 8

NDC: 58809-770-08

Active Ingredients (Active ingredients)

(in each 15 mL)

Pyrilamine Maleate 12.5 mg

Questions Or Comments? (Questions or comments?)

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

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)

{"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.", "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": "■ 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"}