Childrens Sudafed PE description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Sudafed PE

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Childrens Sudafed PE NASAL DECONGESTANT


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Phenylephrine HCl 2.5 mg

Purpose

Nasal decongestant

Use

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

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
  • 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

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 = milliliter; tsp = teaspoonful
  • repeat dose every 4 hours
  • do not use more than 6 times in 24 hours
Age (yr) Dose (mL or tsp)
under 4 years do not use
4 to 5 years 5 mL (1 tsp)
6 to 11 years 10 mL (2 tsp)

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

Childrens Sudafed PE Other information

  • each 5 mL (1 tsp) 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
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

call 1-888-217-2117

PRINCIPAL DISPLAY PANEL

NDC 50580-784-04

NON-DROWSY
children's
SUDAFED PE
®
NASAL
DECONGESTANT

Phenylephrine HCl oral solution
Nasal decongestant

  • Sinus Pressure
    & Stuffy Nose
    Phenylephrine HCl

Due to Colds
& Allergies

Raspberry
Flavor Liquid
Alcohol &
Sugar Free

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

Childrens Sudafed PE

Childrens Sudafed PE

Phenylephrine hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-784
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:50580-784-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-10-01


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Be sure to consult your doctor before taking any medication!
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