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ibuprofen

Kroger Company

Kroger Co. Ibuprofen Oral Suspension Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

ibuprofen 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 doctor’s 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 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 (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

ibuprofen Other information

  • •store at 20-25°C (68-77°F)
  • •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, artificial flavor, butylparaben, FD&C red #40, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of MOTRIN® INFANTS’ DROPS BERRY FLAVOR

See side panel

FOR AGES 6 MOS. TO 23 MOS.

Infants’ Concentrated Drops

Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

No High Fructose Corn Syrup

Alcohol Free

Use Only With Enclosed Syringe

LASTS UP TO 8 HOURS

Berry Flavor

0.5 FL OZ (15 mL)

ibuprofen

ibuprofen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-057
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 50 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLPARABEN
FD&C RED NO. 40
GLYCERIN
HYPROMELLOSES
polysorbate 80
propylene glycol
water
SODIUM BENZOATE
sorbitol
SUCROSE
XANTHAN GUM
ANHYDROUS CITRIC ACID

Product Characteristics

Color
PINK (light)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE
2 NDC:30142-057-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075217 2002-11-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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