CHILDRENS SUDAFED PE COLD PLUS COUGH- dextromethorphan hydrobromide and phenylephrine hydrochloride solution

Childrens SUDAFED PE Cold plus Cough by

Drug Labeling and Warnings

Childrens SUDAFED PE Cold plus Cough by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., Siegfried PharmaChemikalien Minden Gmbh. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

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

Warnings

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.

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

When using this product do not exceed recommended dose

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.

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)

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 bottle wrap, or foil inner seal imprinted "SAFETY SEAL®" 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)

INGREDIENTS AND APPEARANCE

CHILDRENS SUDAFED PE COLD PLUS COUGH 
dextromethorphan hydrobromide and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-785
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan hydrobromide	5 mg  in 5 mL
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	Phenylephrine hydrochloride	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
edetate disodium (UNII: 7FLD91C86K)
FD&C blue NO. 1 (UNII: H3R47K3TBD)
FD&C red NO. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-785-04	1 in 1 CARTON	10/01/2008
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/01/2008

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)