Good Neighbor Pharmacy Childrens Ibuprofen Cold

Dosage form: suspension
Ingredients: IBUPROFEN 100mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 15mg in 5mL
Labeler: Amerisource Bergen
NDC Code: 24385-549

Amerisource Bergen Children's Ibuprofen Cold Drug Facts

Active ingredient (in each 5 mL = teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pseudoephedrine HCl 15 mg

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 an NSAID, which may cause severe stomach bleeding. The chance is higher if your child:

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (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
  • child has problems or serious side effects from taking pain relievers, fever reducers or nasal decongestants
  • the stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • child has asthma
  • child has thyroid disease
  • child has diabetes
  • child is taking a diuretic

Ask a doctor or pharmacist before use if the child is
  • taking any other drug containing pseudoephedrine or any other nasal decongestant
  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product
  • do not exceed recommended dosage
  • give 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
  • child experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • 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
  • wash dosage cup after each use
Dosing Chart
Weight (lb)Age (yrs)Dose (tsp or mL)
under 4 yearsask a doctor
36-47 lbs4 to 5 years1 tsp or 5 mL
48-95 lbs6 to 11 years2 tsp or 10 mL

Other information
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • see bottom of box for lot number and expiration date

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red #40, flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings Information

See New Dosing Directions

COMPARE TO ACTIVE INGREDIENTS IN CHILDREN'S MOTRIN® COLD BERRY FLAVOR

For Ages 4-11

Children’s Ibuprofen Cold

Ibuprofen/Pseudoephedrine HCl

Oral Suspension

100 mg/15 mg per 5 mL (teaspoonful)

Pain Reliever/Fever Reducer (NSAID)

Nasal Decongestant

Relieves:

Stuffy Nose (Pseudoephedrine HCl)

Sore Throat (Ibuprofen)

Fever (Ibuprofen)

Berry Flavor

Alcohol Free

Children's Ibuprofen Cold Carton Image 1

Children's Ibuprofen Cold Carton Image 2

GOOD NEIGHBOR PHARMACY CHILDRENS IBUPROFEN COLD 
ibuprofen, pseudoephedrine hcl suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-549
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
HIGH FRUCTOSE CORN SYRUP 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
XANTHAN GUM 
Product Characteristics
ColorRED (opaque, viscous) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:24385-549-261 BOTTLE (BOTTLE) in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647804/15/1989
Labeler - Amerisource Bergen (007914906)

Revised: 09/2011
 
Amerisource Bergen

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)