Walgreen Co. Children’s Dye-Free Ibuprofen 100 Drug Facts

Walgreen Co. Children’s Dye-Free Ibuprofen 100 Drug Facts

Drug Labeling and Warnings

Drug Details

k">

CHILDRENS IBUPROFEN 100 DYE FREE- ibuprofen suspension 
Walgreen Company

----------

Walgreen Co. Children’s Dye-Free Ibuprofen 100 Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces 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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • 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, kidney disease, or had a stroke
  • child has asthma
  • child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

  • give with food or milk if stomach upset occurs

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
  • child has symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • the child does not get any relief within first day (24 hours) of treatment
  • fever or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

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
  • shake well before using
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dosing cup. Do not use any other dosing device.
  • if needed, repeat dose every 6-8 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 (yr)

Dose (mL)**

under 24 lbs

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL

36-47 lbs

4-5 years

7.5 mL

48-59 lbs

6-8 years

10 mL

60-71 lbs

9-10 years

12.5 mL

72-95 lbs

11 years

15 mL

**or as directed by a doctor

Other information

  • each 5 mL contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • do not freeze

Inactive ingredients

anhydrous citric acid, artificial mixed berry flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Motrin® active ingredient

children’s

Dye-Free Ibuprofen 100

IBUPROFEN ORAL SUSPENSION 100 mg PER 5 mL

PAIN RELIEVER / FEVER REDUCER (NSAID)

DYE FREE

LASTS UP TO 8 HOURS

ALCOHOL FREE

Non-staining

AGES 2 TO 11 YEARS

4 FL OZ (118 mL)

BERRY FLAVOR

SEE NEW WARNINGS

685-94-dye-free-ibuprofen-100.jpg
CHILDRENS IBUPROFEN 100  DYE FREE
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0363-0806
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0363-0806-261 in 1 CARTON02/24/2014
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 0363-0806-281 in 1 CARTON02/24/2014
2148 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 0363-0806-342 in 1 CARTON02/24/2014
3118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493702/24/2014
Labeler - Walgreen Company (008965063)

Revised: 1/2019
 
Walgreen Company


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.