Childrens Sudafed Pe

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (2.5 mg)

Inactive Ingredients

Sodium Citrate, Unspecified Form Sorbitol Solution Sodium Benzoate Sucralose Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Edetate Disodium Fd&c Red No. 40 Glycerin Water

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-10-01

Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

Section 50567-7

When using this product do not exceed recommended dose

Section 50569-3

Ask a doctor before use if the child has

heart disease
high blood pressure
thyroid disease
diabetes
a sodium-restricted diet

Section 50570-1

Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Directions

find right dose on chart below
mL = milliliter
repeat dose every 4 hours
do not use more than 6 times in 24 hours

Age (yr)	Dose (mL)
under 4 years	do not use
4 to 5 years	5 mL
6 to 11 years	10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

each 5 mL contains: sodium 14 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

NDC 50580-784-04

children's

SUDAFED ^®

PE

non-drowsy

NASAL

DECONGESTANT

Phenylephrine HCl Oral Solution

Nasal Decongestant

RELIEF OF

Stuffy Nose
Sinus Pressure

Berry

FLAVOR LIQUID

ALCOHOL &

SUGAR FREE

4 fl oz (118 mL) 2.5 mg per 5 mL

Active Ingredient (in Each 5 Ml)

Phenylephrine HCl 2.5 mg

Structured Label Content

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

heart disease
high blood pressure
thyroid disease
diabetes
a sodium-restricted diet

Section 50570-1 (50570-1)

Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Purpose

Nasal decongestant

Directions

find right dose on chart below
mL = milliliter
repeat dose every 4 hours
do not use more than 6 times in 24 hours

Age (yr)	Dose (mL)
under 4 years	do not use
4 to 5 years	5 mL
6 to 11 years	10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information (Other information)

each 5 mL contains: sodium 14 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments? (Questions or comments?)

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-784-04

children's

SUDAFED ^®

PE

non-drowsy

NASAL

DECONGESTANT

Phenylephrine HCl Oral Solution

Nasal Decongestant

RELIEF OF

Stuffy Nose
Sinus Pressure

Berry

FLAVOR LIQUID

ALCOHOL &

SUGAR FREE

4 fl oz (118 mL) 2.5 mg per 5 mL

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Phenylephrine HCl 2.5 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "50566-9": "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever", "50567-7": "When using this product do not exceed recommended dose", "50569-3": "Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet", "50570-1": "Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.", "Purpose": "Nasal decongestant", "Directions": "find right dose on chart below mL = milliliter repeat dose every 4 hours do not use more than 6 times in 24 hours Age (yr) Dose (mL) under 4 years do not use 4 to 5 years 5 mL 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.", "Other information": "each 5 mL contains: sodium 14 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used. do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing", "Inactive ingredients": "anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "Questions or comments?": "call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-784-04 children's SUDAFED ® PE non-drowsy NASAL DECONGESTANT Phenylephrine HCl Oral Solution Nasal Decongestant RELIEF OF Stuffy Nose Sinus Pressure Berry FLAVOR LIQUID ALCOHOL & SUGAR FREE 4 fl oz (118 mL) 2.5 mg per 5 mL", "Active ingredient (in each 5 mL)": "Phenylephrine HCl 2.5 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information