Childrens SUDAFED PE Cold and Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens SUDAFED PE Cold and Cough

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Childrens SUDAFED PE Cold and Cough


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5 mL)5 mL = one teaspoon Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Phenylephrine HCl 2.5 mg Nasal decongestant

Use

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

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
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours
  • do not give more than 6 times in 24 hours.
Age (yr) Dose (tsp)
under 4 years do not use
4 to 5 years 1 teaspoonful (5 mL)
6 to 11 years 2 teaspoonfuls (10 mL)

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

Childrens SUDAFED PE Cold and Cough Other information

  • each teaspoon contains: sodium 15 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 blue #1, 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 50580-785-04

NON-DROWSY
children's
SUDAFED PE
®
COLD &
COUGH

  • Sinus Pressure
    & Stuffy Nose
    Phenylephrine HCl
  • Cough
    Dextromethorphan
    HBr

Grape
Flavor Liquid
Alcohol & Sugar Free

4 fl oz (118 mL)

Childrens SUDAFED PE Cold and Cough

Childrens SUDAFED PE Cold and Cough

Dextromethorphan hydrobromide and Phenylephrine hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-785
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:50580-785-04 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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