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NDC 53329-0673-30 Ibuprofen 200 mg/1 Details
Ibuprofen 200 mg/1
Ibuprofen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Medline Industries. 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: 53329-0673-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 53329-0673 |
|---|---|
| Product ID | 53329-673_f683cca6-3747-4ac8-9165-f34d4147bb97 |
| 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 | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN |
| Labeler Name | Medline Industries |
| 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 | ANDA079174 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 53329-0673-30 (53329067330)
| NDC Package Code | 53329-673-30 |
|---|---|
| Billing NDC | 53329067330 |
| Package | 1 BOTTLE in 1 BOX (53329-673-30) / 100 TABLET in 1 BOTTLE |
| Marketing Start Date | 2013-01-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8a0aa98e-cd07-44fe-ba4c-ef3af4066c68 Details
Active Ingredient (in each 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 an seek medical help right away.
Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance are higher if you:
- are age 60 or oder
- have had stomach ulders or bleeding problems
- take blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks everyday while using this prdouct
- take more or for a longer time than directed.
Do not use
- if you ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- you have problems or serious side effects from taking pain relievers or fever reducers
- the 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 have asthma
- you are taking a diuretic.
Ask a doctor or pharmacist before use if you are
- taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor's care for any serious condition
- taking any other drug.
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
- vomit blood
- have bloody or black stools
- have stomach pain that does not bet better
- Pain gets worse or last more than 10 days
- Fever gets worse or last more than 3 days
- Redness or swelling is present in the painful area
- Any new symptoms appear
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Directions
- do not take more than directed
- the smallest effective dose should be used
| Adults and children 12 years and older |
|
| children under 12 years |
|
Inactive Ingredients
Principal Display Panel
†Compare to the active ingredient in ADVIL®
Ibuprofen Tablets USP
Pain Reliever/ Fever Reducer (NSAID)*
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®
DO NOT USE IF IMPRINTED FOIL UNDER CAP IS BROKEN OR MISSING
READ ALL WARNINGS AND DIRECTIONS BEFORE USE. KEEP CARTON.
PRODUCT OF INDIA
Distributed by:
Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
INGREDIENTS AND APPEARANCE
| IBUPROFEN
ibuprofen tablet |
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| Labeler - Medline Industries (025460908) |
| Registrant - P & L Development, LLC (079765031) |