Ibuprofenchildrens suspension

Active ingredient (in each 5 ml = 1 teaspoonful)

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

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
  • 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, or kidney disease
  • child has asthma
  • child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

  • under a doctors care for any serious condition
  • taking any other drug

When using this product

  • 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 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; tsp = teaspoonful
  • 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

Dosage Chart

Weight (lb)

Age (yr)

Dose (mL or tsp)**

under 24 lbs

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL (1 tsp)

35-47 lbs

4-5 years

7.5 mL (1 tsp)

48-59 lbs

6-8 years

10 mL (2 tsp)

60-71 lbs

9-10 years

12.5 mL (2 tsp)

72-95 lbs

11 years

15 mL (3 tsp)

**or as directed by a doctor

Other information

  • each 5 mL (1 tsp) 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
  • see bottom panel for lot number and expiration date

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Ibuprofenchildrens suspension- Ibuprofen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-0040
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 100 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Hypromelloses ( UNII: 3NXW29V3WO)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color ORANGE Flavor FRUIT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA074937 USA

Labeler - Walgreen Company( 008965063)

Package/label principal display panel

childrens

For ages 2 to 11 years

Ibuprofen 100

Ibuprofen Oral Suspension

100 mg per 5 mL

Pain Reliever / Fever Reducer (NSAID)

Alcohol free

8

LASTS UP TO 8 HOURS

BERRY FLAVOR

4 FL OZ (118 mL)