Label: GOOD SENSE IBUPROFEN- ibuprofen tablet, chewable
- NDC Code(s): 63187-856-24
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0113-0461
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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:
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- has had stomach ulcers or bleeding problems
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- takes a blood thinning (anticoagulant) or steroid drug
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- takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- 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
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- if the child has ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- stomach bleeding warning applies to your child
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- child has a history of stomach problems, such as heartburn
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- child has problems or serious side effects from taking pain relievers or fever reducers
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- child has not been drinking fluids
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- child has lost a lot of fluid due to vomiting or diarrhea
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- child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- child has asthma
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- child is taking a diuretic
Ask a doctor or pharmacist before use if the child is
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- under a doctor’s care for any serious condition
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- taking any other drug
When using this product
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- mouth or throat burning may occur; give with food or water
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- take with food or milk if stomach upset occurs
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- 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
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- child experiences any of the following signs of stomach bleeding:
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- feels faint
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- vomits blood
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- has bloody or black stools
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- has stomach pain that does not get better
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- the child does not get any relief within the first day (24 hours) of treatment
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- fever or pain gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
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Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed
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- find the right dose on chart below. If possible, use weight to dose; otherwise use age.
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- if needed, repeat dose every 6-8 hours
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- 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
- Inactive ingredients
- Questions or comments?
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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
Manufactured by:
Perrigo Allegan, MI 49010
Relabeled by:
Proficient Rx LP Thousand Oaks, CA 91320
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INGREDIENTS AND APPEARANCE
GOOD SENSE IBUPROFEN
ibuprofen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-856(NDC:0113-0461) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SOYBEAN OIL (UNII: 241ATL177A) SUCCINIC ACID (UNII: AB6MNQ6J6L) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) Product Characteristics Color ORANGE Score 2 pieces Shape ROUND Size 13mm Flavor ORANGE Imprint Code L461 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-856-24 1 in 1 CARTON 06/01/2017 1 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076359 11/09/2004 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-856)
