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NDC 63187-0598-06 Ibuprofen 200 mg/1 Details
Ibuprofen 200 mg/1
Ibuprofen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is IBUPROFEN.
MedlinePlus Drug Summary
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 63187-0598-06Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 63187-0598 |
|---|---|
| Product ID | 63187-598_72a68ee9-c480-4fce-be2f-8bb614cd0d52 |
| Associated GPIs | 66100020000305 |
| GCN Sequence Number | 008346 |
| GCN Sequence Number Description | ibuprofen TABLET 200 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 35743 |
| HICL Sequence Number | 003723 |
| HICL Sequence Number Description | IBUPROFEN |
| Brand/Generic | Generic |
| Proprietary Name | Ibuprofen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ibuprofen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63187-0598-06 (63187059806)
| NDC Package Code | 63187-598-06 |
|---|---|
| Billing NDC | 63187059806 |
| Package | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-598-06) |
| Marketing Start Date | 2015-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3b82255b-151a-4e5f-8099-b4da719867ac Details
Active ingredient (in each brown tablet)
Uses
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 you:
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Do not use
- right before or after heart surgery
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
Ask a doctor before use if you have
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- •
- taking any other drug
- •
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- •
- under a doctor"s care for any serious condition
When using this product
- 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
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
Directions
- do not take more than directed
- the smallest effective dose should be used
- 1.
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Other information
Inactive ingredients
Principal Display Panel
NDC 63187-598-30
†Compare to the active ingredient in Advil® Tablets
Ibuprofen
Tablets
Ibuprofen Tablets, USP 200 mg
Pain Reliever
Fever Reducer (NSAID)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV0112D29116
Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17 Rev.01/13
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Re-order No. 700643
INGREDIENTS AND APPEARANCE
| IBUPROFEN
ibuprofen tablet, film coated |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(63187-598) , RELABEL(63187-598) | |