Good sense infants ibuprofen suspension/ drops

Active ingredient (in each 1.25 ml)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • measure with the dosing device provided. Do not use with any other device.
  • dispense liquid slowly into the childs mouth, toward the inner cheek
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day

Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

Other information

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

Inactive ingredients

anhydrous citric acid, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Good sense infants ibuprofen suspension/ drops- Ibuprofen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0113-0040
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 50 mgin 1.25 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Glycerin ( UNII: PDC6A3C0OX)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sucrose ( UNII: C151H8M554)
Xanthan gum ( UNII: TTV12P4NEE)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color WHITE (Opaque) Flavor BERRY (mixed)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075217 USA

Labeler - L. Perrigo Company( 006013346)

Principal display panel

For Ages 6 to 23 mos.

Infants CONCENTRATED DROPS

Ibuprofen Oral Suspension 50 mg per 1.25 mL

Pain Reliever/Fever Reducer

(NSAID)

Dye-Free

Non-Staining

Lasts Up To 8 Hours

No High Fructose Corn Syrup

Use Only With Enclosed Syringe

Berry Flavor

Compare to active ingredients of Motrin® Infants Drops

100% SATISFACTION GUARANTEED

1 FL OZ (30 mL)