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NDC 60760-0941-24 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 St. Mary's Medical Park Pharmacy. 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: 60760-0941-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
NDC | 60760-0941 |
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Product ID | 60760-941_a19cb05b-6e35-b88c-e053-2a95a90a64e4 |
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 | St. Mary's Medical Park Pharmacy |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA075010 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 60760-0941-24 (60760094124)
NDC Package Code | 60760-941-24 |
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Billing NDC | 60760094124 |
Package | 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-941-24) |
Marketing Start Date | 2020-03-24 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a19ca6ca-b7c3-6a3d-e053-2995a90a8180 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:
- shock
- hives
- facial swelling
- asthma (wheezing)
- 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:
- are age 60 or older
- 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
Heart attack and stroke warning: NSAIDs, except aspirin, increase
the risk of heart attack, heart failure, and stroke. These can be
fatal. The risk is higher if you use more than directed or for
longer than directed.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because
ibuprofen may decrease this benefit of aspirin - taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain - trouble breathing - leg swelling
- slurred speech - weakness in one part or side of body - pain gets worse or lasts more than 10 days
- redness or swelling is present in the painful area
- fever gets worse or lasts more than 3 days
- any new symptoms occur
If pregnant or breast-feeding,
ask a health professional before use. it is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Directions
- do not use more than directed
- the smallest effective dose should be used
- 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 take more than 6 tablets in 24 hours unless directed by a doctor
- children under 12 years: ask a doctor
Inactive ingredients
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coated |
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Labeler - St. Mary's Medical Park Pharmacy (063050751) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
St. Mary's Medical Park Pharmacy | 063050751 | relabel(60760-941) , repack(60760-941) |