Children's Sudafed Pe Cold Plus Cough

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-10-01

Medication Information

Description

Drug Facts

Uses

temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:
- cough
- nasal congestion
- 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
cough gets worse or lasts for more than 7 days
cough tends to come back or occurs with fever, rash or headache that lasts

These could be signs of a serious condition.

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
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)
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.

Section 55105-1

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Directions

find right dose on chart below
mL = milliliters
repeat dose every 4 hours
do not give 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 blue no. 1, 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 50580-785-04

children's

SUDAFED ^®

PE

non-drowsy

COLD + COUGH

Phenylephrine HCl • Dextromethorphan HBr

Nasal Decongestant • Cough Suppressant

Oral Solution

RELIEF OF

Stuffy Nose
Sinus Pressure
Cough

Grape

FLAVOR LIQUID

ALCOHOL &

SUGAR FREE

4 ﬂ oz (118 mL)

Structured Label Content

Uses

temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:
- cough
- nasal congestion
- 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
cough gets worse or lasts for more than 7 days
cough tends to come back or occurs with fever, rash or headache that lasts

These could be signs of a serious condition.

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
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)
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.

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Directions

find right dose on chart below
mL = milliliters
repeat dose every 4 hours
do not give 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 blue no. 1, 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 50580-785-04

children's

SUDAFED ^®

PE

non-drowsy

COLD + COUGH

Phenylephrine HCl • Dextromethorphan HBr

Nasal Decongestant • Cough Suppressant

Oral Solution

RELIEF OF

Stuffy Nose
Sinus Pressure
Cough

Grape

FLAVOR LIQUID

ALCOHOL &

SUGAR FREE

4 ﬂ oz (118 mL)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies: cough nasal congestion 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 cough gets worse or lasts for more than 7 days cough tends to come back or occurs with fever, rash or headache that lasts These could be signs of a serious condition.", "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 persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) 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.", "55105-1": "Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant", "Directions": "find right dose on chart below mL = milliliters repeat dose every 4 hours do not give 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 blue no. 1, 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 50580-785-04 children's SUDAFED ® PE non-drowsy COLD + COUGH Phenylephrine HCl • Dextromethorphan HBr Nasal Decongestant • Cough Suppressant Oral Solution RELIEF OF Stuffy Nose Sinus Pressure Cough Grape FLAVOR LIQUID ALCOHOL & SUGAR FREE 4 ﬂ oz (118 mL)"}

Children's Sudafed Pe Cold Plus Cough

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information