Good Sense Ibuprofen: Package Insert and Label Information

GOOD SENSE IBUPROFEN- ibuprofen tablet, chewable
Dispensing Solutions, Inc.

Active ingredient (in each tablet)

Ibuprofen 100 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 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

  • mouth or throat burning may occur; give with food or water
  • take 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 the 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
  • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
Dosing Chart
Weight (lb) Age (yr) Tablets
under 24 under 2 ask a doctor
24-35 2-3 1
36-47 4-5 1 ½
48-59 6-8 2
60-71 9-10 2 ½
72-95 11 3

Other information

  • phenylketonurics: contains phenylalanine 6 mg per tablet
  • do not use if printed seal under cap is broken or missing
  • store at 20-25°C (68-77°F)
  • see end panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

For Ages 2 to 11

See New Warnings Information

Junior Strength Ibuprofen Tablets, 100 mg

Lasts Up To 8 Hours

Pain Reliever / Fever Reducer (NSAID)

Orange Flavor

Compare to active ingredient of Motrin® Junior Strength

NDC 68258-2994-02

NDC 68258-2994-02
(click image for full-size original)
GOOD SENSE IBUPROFEN
ibuprofen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-2994(NDC:0113-0461)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CARNAUBA WAX
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SOYBEAN OIL
SUCCINIC ACID
ACESULFAME POTASSIUM
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 13mm
Flavor ORANGE Imprint Code L461
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68258-2994-2 24 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076359 11/09/2004
Labeler — Dispensing Solutions, Inc. (066070785)
Registrant — PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (68258-2994), repack (68258-2994)

Revised: 11/2013 Dispensing Solutions, Inc.

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