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Childrens Motrin Cold

Generic Name: ibuprofen and pseudoephedrine hydrochloride
Dosage Form: suspension

Children's
Motrin®
COLD

Drug Facts

Active ingredients (in each 5 mL = 1 teaspoon)

Ibuprofen 100 mg (NSAID)1

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Pseudoephedrine HCl 15 mg

1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

  • temporarily relieves these cold, sinus and flu symptoms:
    • nasal and sinus congestion
    • stuffy nose
    • headache
    • sore throat
    • minor body aches and pains
    • fever

Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the child:

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
  • takes more or for a longer time than directed

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use

  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer and/or nasal decongestant
  • right before or after heart surgery
  • 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

  • problems or serious side effects from taking pain relievers, fever reducers, or nasal decongestants
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • not been drinking fluids
  • lost a lot of fluid due to vomiting or diarrhea
  • high blood pressure
  • heart or kidney disease
  • asthma
  • thyroid disease
  • diabetes
  • taken a diuretic

Ask a doctor or pharmacist before use if the child is

  • taking any other drug containing an NSAID (prescription or nonprescription) and/or pseudoephedrine or any other nasal decongestant
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • do not exceed recommended dosage
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
  • stomach pain or upset gets worse or lasts
  • the child does not get any relief within first day (24 hours) of treatment
  • fever, pain, or nasal congestion gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • the child gets nervous, dizzy, or sleepless

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

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • do not give longer than 10 days, unless directed by a doctor (see Warnings)
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • only use enclosed measuring cup
  • if needed, repeat dose every 6 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
Dosing Chart
Weight (lb) Age (yrs) Dose (tsp or mL)
under 24 under 2 ask a doctor
24-47 2 to 5 1 tsp or 5 mL
48-95 6 to 11 2 tsp or 10 mL

Other information

  • store between 20-25°C (68-77°F)
  • do not use if bottle wrap, or foil inner seal imprinted with "Safety Seal®" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Questions or comments?

Call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish): weekdays 9:00 AM to 4:30 PM EST

PRINCIPAL DISPLAY PANEL

NDC 50580-902-04

For Ages 2 to 11

Children's
Motrin®
COLD

contains Ibuprofen (NSAID)
Pseudoephedrine HCl
Oral Suspension
100 mg/15 mg per 5 mL (teaspoon)

Pain Reliever/Fever Reducer/Nasal Decongestant

Relieves:

Stuffy Nose
(Pseudoephedrine HCl)

Sore Throat
(Ibuprofen)

Fever
(Ibuprofen)

Original
Berry Flavor
Alcohol Free

4 FL OZ (120 mL)

CHILDRENS MOTRIN  COLD
ibuprofen and pseudoephedrine hydrochloride suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-902
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (Ibuprofen) Ibuprofen 100 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 15 mg  in 5 mL
Product Characteristics
Color RED, ORANGE Score     
Shape Size
Flavor BERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:50580-902-04 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1 120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021128 08/01/2000
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
Revised: 10/2009
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc



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