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NDC 49483-0612-00 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 TIME CAP LABORATORIES,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: 49483-0612-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 49483-0612 |
|---|---|
| Product ID | 49483-612_3aacf896-adf0-47fb-9cc4-a85ee9f61367 |
| 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, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN |
| Labeler Name | TIME CAP LABORATORIES,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 | ANDA091237 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49483-0612-00 (49483061200)
| NDC Package Code | 49483-612-00 |
|---|---|
| Billing NDC | 49483061200 |
| Package | 6500 TABLET, FILM COATED in 1 BAG (49483-612-00) |
| Marketing Start Date | 2016-11-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 82aad715-f652-471b-840c-5151c66e5ade Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
do not take more than directed
the smallest effective dose should be used
do not take longer than 10 days, unless directed by a docter
(see Wanings)
adults and children 12 years and olderChildren under 12 years
take 1 tablet every 4 to 6 hours while symptoms persistif 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.
ask a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include: asthma (wheezing),blisters,facial swelling,hives,rash,shock,skin reddening
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 stomach bleeding. The chance is higher if you:are age 60 or older; have bad stomach ulcers or bleeding problems;take a blood thinning (anticoagulant) or steroid drug; take other drug containing prescription NSAID (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
INGREDIENTS AND APPEARANCE
| IBUPROFEN
ibuprofen tablet, film coated |
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| IBUPROFEN
ibuprofen tablet, film coated |
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| Labeler - TIME CAP LABORATORIES,INC (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| MARKSANS PHARMA LIMITED | 925822975 | manufacture(49483-611, 49483-612) | |