Ibuprofen (Page 4 of 4)

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with ibuprofen tablets the dose and frequency should be adjusted to suit an individual patient’s needs.

Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer Ibuprofen Tablets, USP with meals or milk.

Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease:

Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid).

Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.

The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.

The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption). The availability of four tablet strengths facilitates dosage adjustment.

In chronic conditions , a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient’s dose should be reviewed and adjusted as required.

Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.

In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.

Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.

HOW SUPPLIED

Ibuprofen Tablets, USP are available in the following strengths, colors and sizes:

400 mg (white, round, biconvex, aqueous film-coated tablets, debossed “IP 464” on obverse and plain on reverse.

They are available as follows:

Bottles of 30: NDC 60429-092-30

Bottles of 60: NDC 60429-092-60

Bottles of 90: NDC 60429-092-90

600 mg (white, oval-shaped, biconvex, aqueous film-coated tablets, debossed “IP 465” on obverse and plain on reverse.

They are available as follows:

Bottles of 30: NDC 60429-093-30

Bottles of 60: NDC 60429-093-60

Bottles of 90: NDC 60429-093-90

800 mg (white, capsule-shaped, biconvex, aqueous film-coated tablets, debossed “IP 466” on obverse and plain on reverse.

They are available as follows:

Bottles of 9: NDC 60429-094-09

Bottles of 18: NDC 60429-094-18

Bottles of 30: NDC 60429-094-30

Bottles of 90: NDC 60429-094-90

Bottles of 270: NDC 60429-094-27

Store at controlled room temperature 20° to 25°C (68° to 77°F)[see USP].

Rx only

Manufactured by: Amneal Pharmaceuticals of NY , Hauppauge, NY 11788

Marketed/Packaged by: GSMS Inc. , Camarillo, CA 93012

Rev. 09-2009

PRINCIPAL DISPLAY PANEL — 400 mg 30s

Label Graphic -- 400 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 600mg 30s

Label Graphic -- 600 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 800 mg

Label Graphic -- 800 mg
(click image for full-size original)
IBUPROFEN
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-092(NDC:53746-464)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 400 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 13mm
Flavor Imprint Code IP;464
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-092-30 30 TABLET in 1 BOTTLE None
2 NDC:60429-092-60 60 TABLET in 1 BOTTLE None
3 NDC:60429-092-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 11/23/2009
IBUPROFEN
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-093(NDC:53746-465)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 600 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL (Biconvex) Size 17mm
Flavor Imprint Code IP;465
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-093-30 30 TABLET in 1 BOTTLE None
2 NDC:60429-093-60 60 TABLET in 1 BOTTLE None
3 NDC:60429-093-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 11/23/2009
IBUPROFEN
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-094(NDC:53746-466)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL (Biconvex) Size 19mm
Flavor Imprint Code IP;466
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-094-30 30 TABLET in 1 BOTTLE None
2 NDC:60429-094-90 90 TABLET in 1 BOTTLE None
3 NDC:60429-094-27 270 TABLET in 1 BOTTLE None
4 NDC:60429-094-09 9 TABLET in 1 BOTTLE None
5 NDC:60429-094-18 18 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 11/23/2009
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 REPACK (60429-092), REPACK (60429-093), REPACK (60429-094), RELABEL (60429-092), RELABEL (60429-093), RELABEL (60429-094)

Revised: 01/2012 Golden State Medical Supply, Inc.

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