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NDC 69452-0239-22 Ibuprofen 200 mg/1 Details
Ibuprofen 200 mg/1
Ibuprofen is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Bionpharma Inc.. 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: 69452-0239-22Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
NDC | 69452-0239 |
---|---|
Product ID | 69452-239_8a81171c-e615-44f0-917b-a520ff7cb07c |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Ibuprofen |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Ibuprofen |
Product Type | HUMAN OTC DRUG |
Dosage Form | CAPSULE, LIQUID FILLED |
Route | ORAL |
Active Ingredient Strength | 200 |
Active Ingredient Units | mg/1 |
Substance Name | IBUPROFEN |
Labeler Name | Bionpharma Inc. |
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 | ANDA078682 |
Listing Certified Through | 2024-12-31 |
Package
Package Images


NDC 69452-0239-22 (69452023922)
NDC Package Code | 69452-239-22 |
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Billing NDC | 69452023922 |
Package | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-239-22) |
Marketing Start Date | 2019-08-02 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d7d00fe3-c537-486e-8156-9b56b550bff5 Details
Active ingredient (in each orange oval capsule)
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
- 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 be fatal. The risk is higher if you use more than directed or for longer than directed.
Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month.
Do not use
Ask a doctor before use if
- you have never had migraines diagnosed by a health professional
- you have a headache that is different from your usual migraines
- you have the worst headache of your life
- you have fever and stiff neck
- you have headaches beginning after or caused by head injury, exertion, coughing or bending
- you have experienced your first headache after the age of 50
- you have daily headaches
- you have a migraine so severe as to require bed rest
- 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, asthma, or had a stroke
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
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
- weakness in one part or side of body
- slurred speech
- leg swelling
- migraine headache pain is not relieved or gets worse after the first dose
- any new symptoms appear
If pregnant or breast-feeding,
Keep out of reach of children.
Directions
Other information
Inactive ingredients
Questions or comments?
call toll free 1-888-235-2466
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil® Migraine.
Manufactured for:
Bionpharma Inc.
600 Alexander Road,
Princeton, NJ 08540
Rev # 07/19
L0000230
120's Bottle lable
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filled |
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Labeler - Bionpharma Inc. (079637826) |
Registrant - Bionpharma Inc. (079637826) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Patheon Softgels Inc. | 002193829 | manufacture(69452-239) |