CHILDRENS MOTRIN COLD- ibuprofen and pseudoephedrine hydrochloride suspension
McNeil Consumer Healthcare Div McNeil-PPC, Inc
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Active ingredients (in each 5 mL = 1 teaspoon)
Ibuprofen 100 mg (NSAID)1
Pseudoephedrine HCl 15 mg
- 1
- nonsteroidal anti-inflammatory drug
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
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
| 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 |
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| Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358) |