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NDC 63654-0363-40 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 Selder, S.A. de C.V.. 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: 63654-0363-40Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 63654-0363 |
|---|---|
| Product ID | 63654-363_82a1d588-5ad1-4ab9-8bdb-bfa044823dee |
| 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 | Softgels |
| Non-Proprietary Name | Ibuprofen 200 mg |
| 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 | Selder, S.A. de C.V. |
| 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 | ANDA079205 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63654-0363-40 (63654036340)
| NDC Package Code | 63654-363-40 |
|---|---|
| Billing NDC | 63654036340 |
| Package | 1 BOTTLE in 1 CARTON (63654-363-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE |
| Marketing Start Date | 2014-12-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6f1b4964-4eb8-459c-9cb8-92ea93103f5b Details
Active ingredient
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.
The chances are 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.
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
■ 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, or kidney disease
■ you have 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
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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
Keep out of reach of children
Directions
- do not take more than directed
- the smallest effective dose should be used
- Adults and children 12 years and older: take 1 softgel every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 softgel, 2 softgels may be used
- do not exceed 6 softgels in 24 hours, unless directed by a doctor
- Children under 12 years: ask a doctor
Inactive Ingredients
INGREDIENTS AND APPEARANCE
| IBUPROFEN
SOFTGELS
ibuprofen 200 mg capsule, liquid filled |
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| Labeler - Selder, S.A. de C.V. (824413629) |