Health Sense Infants Ibuprofen Oral Suspension: Package Insert and Label Information

HEALTH SENSE INFANTS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension
Dolgencorp Inc

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

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 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
  • right before or after heart surgery

Ask a doctor before use if the child has

  • problems or serious side effects from taking pain relievers or fever reducers
  • 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
  • taken a diuretic

Ask a doctor or pharmacist before use if the child is

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • 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

  • give with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

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 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.

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 the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • measure with dosing device provided. Do not use with any other device.
  • dispense liquid slowly into the child’s 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 (lb) 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

  • 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

artificial flavor, butylparaben, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Questions or comments?

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Compare to active ingredient of Motrin® Infants’ Drops

Concentrated

For Ages 6 mos.-23 mos.

Infants’ Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Alcohol Free

Use Only With Enclosed Syringe

Berry Flavor

Product Carton

Product Carton

Product Label

Product Label

HEALTH SENSE INFANTS IBUPROFEN ORAL SUSPENSION
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 50 mg in 1.25 mL
Product Characteristics
Color PINK (light) Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-057-05 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (55910-057-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075217 06/08/2009
Labeler — Dolgencorp Inc (068331990)

Revised: 05/2009 Dolgencorp Inc

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